| Primary | Retear Rate at 6 Months | Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images). | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Number | 95% Confidence Interval | percentage of retears | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 | ARCR Alone | The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement. | | OG002 | Revision Group | Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00057.14(40.96 to 72.28)
- OG00150.00(34.19 to 65.81)
- OG00242.11(20.25 to 66.50)
|
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| |
| Secondary | Number of Retears at 3 Months, 12 Months, and 24 Months | Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images). | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Count of Participants | | Participants | | 3 months, 12 months, and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
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| Secondary | Oxford Shoulder Score (OSS) | The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes. | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Seven participants had out of range scores (i.e., scores were greater than the highest score possible) and were not included for analysis. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
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| Secondary | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome). | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
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| Secondary | Constant-Murley Score | The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome). | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Six participants had out of range scores (i.e., scores were greater than the highest score possible) and were not included for analysis. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
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| Secondary | Subjective Shoulder Value (SSV) | The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome. | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
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| Secondary | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the participant's health state and consists of five dimensions to create an index score for mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome. | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome). | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
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| Secondary | Patient Satisfaction Questionnaire: Medical Care | The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question "How satisfied are you with your medical care?". Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied. | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
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| Secondary | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery relieve the pain?" with one of the following responses:
- Excellent
- Very Good
- Good
- Fair
- Poor
| The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery improve your ability to perform regular activities?" with one of the following responses:
- Excellent
- Very Good
- Good
- Fair
- Poor
| The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery allow you to perform heavy work or sport activities?" with one of the following responses:
- Excellent
- Very Good
- Good
- Fair
- Poor
| The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery meet your expectations?" with one of the following responses:
- Excellent
- Very Good
- Good
- Fair
- Poor
| The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "Would you repeat the operation again if needed on another joint?" with one of the following responses:
- Definitely Yes
- Probably Yes
- Possibly Not
- Definitely Not
| The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Pain - Visual Analog Scale (VAS) Score | Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome). | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Data not collected for ARCR+Regeneten subjects at 3 months. | Posted | | Mean | Standard Deviation | score on a scale | | 2 weeks, 6 weeks, 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | MRI Tendon Findings: Supraspinatus Sugaya Score | The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear. | The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. Baseline score not collected as all participants had full-thickness tears. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | MRI Tendon Findings: Infraspinatus Sugaya Score | The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear. | The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. Baseline score not collected as all participants had full-thickness tears. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | MRI Tendon Findings: Supraspinatus Goutallier Classification | Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following:
- Grade 0
- Grade I
- Grade 2
- Grade 3
- Grade 4
- Unable to assess
| The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | MRI Tendon Findings: Infraspinatus Goutallier Classification | Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following:
- Grade 0
- Grade I
- Grade 2
- Grade 3
- Grade 4
- Unable to assess
| The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Total Tendon Thickness | Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI). | The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. No (0) ARCR alone subjects tendon thickness at 24 months could be reported as no data was collected because relevant images were missing, not available, or relevant anatomy not visible in field of view. | Posted | | Mean | Standard Deviation | millimeters (mm) | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Total Tendon Length | Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI). | The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Mean | Standard Deviation | millimeters (mm) | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 | ARCR Alone |
|
| Secondary | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | Area of retear in millimeters squared (mm^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI). | The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. | Posted | | Mean | Standard Deviation | millimeters squared (mm^2) | | Day 0, 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 | ARCR Alone | |
|
| Secondary | Size of Retear: Anteroposterior (AP) Length | Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI). | The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. | Posted | | Mean | Standard Deviation | millimeters (mm) | | Day 0, 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 | ARCR Alone | |
|
| Secondary | Size of Retear: Mediolateral (ML) Length | Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI). | The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. | Posted | | Mean | Standard Deviation | millimeters (mm) | | Day 0, 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 | ARCR Alone | |
|
| Secondary | Shape of Retear: Operative Visit | Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes:
- Crescent
- L Shape
- Reverse L
- U Shape
- Massive/Contracted
- Unable to Determine
| The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. | Posted | | Count of Participants | | Participants | | Day 0 | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 | ARCR Alone |
|
| Secondary | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes:
- Intact (i.e., no re-tear)
- Crescent
- Longitudinal
- Massive
- Unable to Determine
| The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. | Posted | | Count of Participants | | Participants | | 3 months, 6 months, 12 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Return to Work Questionnaire | Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions:
- Returned to work?
- Have you been able to return to the job you did before your surgery?
- Did you feel ready to go back to work physically?
- Since returning to work, any time off due to shoulder pain or weakness?
- Since last follow-up visit did you take additional time off due to shoulder pain/weakness?
| The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Each group with 0 participants analyzed for "Since last follow-up visit did you take additional time off..." question at 2 weeks, 6 weeks, 3 months, & 6 months indicated no responses were provided (i.e., data not collected). | Posted | | Count of Participants | | Participants | | 2 weeks, 6 weeks, 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Return to Work Questionnaire: Reason for Not Getting Back to Work | The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Returned to work?" question were asked to provide a reason for not getting back to work from one of the following options:
- Physical capability
- Safety
- Motivation
- Other
| The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Count of Participants | | Participants | | 2 weeks, 6 weeks, 3 months, 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Return to Work Questionnaire: Reason Couldn't Return to Activities | The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Have you been able to return to the job you did before your surgery?" question were asked to provide a reason for not getting back to work from one of the following options:
- Physical capability
- Safety
- Motivation
- Other
| The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Count of Participants | | Participants | | 2 weeks, 6 weeks, 3 months, 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Return to Work Questionnaire: Time Off | Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Since returning to work, any time off due to shoulder pain or weakness?" question were asked to provide how long they have taken off in days. | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Mean | Standard Deviation | days | | 2 weeks, 6 weeks, 3 months, 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Return to Work Questionnaire: Duration Away From Work (Days) | Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Returned to work?" question were asked to provide the number of days taken away from work | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Data not collected for 2 subjects who responded yes at 6 months in ARCR alone group. | Posted | | Mean | Standard Deviation | days | | 2 weeks, 6 weeks, 3 months, 6 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. |
|
| Secondary | Duration of Opioid Use | Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery. | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Mean | Standard Deviation | days | | Following surgery, up to 14 days | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 | ARCR Alone |
|
| Secondary | Opioid Use for More Than 5 Days Post-Surgery | Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery. | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Count of Participants | | Participants | | Following surgery, up to 14 days | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 |
|
| Secondary | Total Operative Time | Total operative time in minutes. | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Mean | Standard Deviation | minutes | | Intraoperative | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 | ARCR Alone | The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement. |
|
| Secondary | Sling Type | The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following:
- Standard Sling
- Shoulder Immobilizer
- Sling and Swathe
- Abduction Sling
- External Rotation Sling
- Other
- Missing
| The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Count of Participants | | Participants | | up to 3 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 |
|
| Secondary | Mobilization Time in Sling | Mobilization time was the duration, measured in weeks, that participants spent in a sling. | The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. | Posted | | Mean | Standard Deviation | weeks | | up to 3 months | | | | ID | Title | Description |
|---|
| OG000 | ARCR Augmented With REGENETEN™ Bioinductive Implant | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | | OG001 | ARCR Alone | The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement. |
|