| Primary | American Shoulder and Elbow Surgeons (ASES) Score | American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome. | Overall number of participants with available data for each treatment at the time frame indicated | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and 3 months | | | | ID | Title | Description |
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| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG00055
- ParticipantsOG00156
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| Secondary | American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery | American Shoulder and Elbow Surgeons (ASES) score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome. | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2,Week 3,Week 4,Week 5,Week 6,Week 7,Week 8,Week 9,Week 10,Week 11, & Week 12 | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery | Single Assessment Numeric Evaluation (SANE) score at baseline and weekly up to 12 weeks (3 months). SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?'' | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery | Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome). | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | American Shoulder and Elbow Surgeons (ASES) score at baseline, 6, 12, 18 and 24 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome. | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 6 months, 12 months, 18 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Single Assessment Numeric Evaluation (SANE) score at baseline, 6, 12, 18 and 24 months following index surgery. SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?'' | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 6 months, 12 months, 18 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months | Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline, 6, 12, 18 and 24 months following index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome). | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 6 months, 12 months, 18 months and 24 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months | Constant-Murley Score at baseline, 3, 6, 12, and 24 months following index surgery. The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The test is divided into four subscales: pain, activities of daily living, strength, and range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder). Constant-Murley Scores range from 0 to 100, with higher scores indicating better shoulder function & lower scores indicating worse shoulder function. | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 months, 6 months, 12 months, and 24 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose. | Overall number of participants with available data for the treatment and time frame indicated. One extreme outlier was excluded from the Arthroscopic repair treatment group due to a data irregularity. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis. | Posted | | Mean | Standard Deviation | defined daily dose | | Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | |
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| Secondary | Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery | Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose. | Overall number of participants with available data for the treatment and time frame indicated. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis. | Posted | | Mean | Standard Deviation | defined daily dose | | Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness |
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| Secondary | Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose. | Overall number of participants with available data for the treatment and time frame indicated. One extreme outlier was excluded from the Arthroscopic repair treatment group due to a data irregularity. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis. | Posted | | Mean | Standard Deviation | defined daily dose | | Directly after surgery, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 |
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| Secondary | Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months | Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose. | Overall number of participants with available data for the treatment and time frame indicated. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis. | Posted | | Mean | Standard Deviation | defined daily dose | | Directly after surgery, 6 months, and 12 months | | | | ID | Title | Description |
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| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness |
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| Secondary | Duration of Shoulder Immobilization | Duration of shoulder immobilization measured as days spent in a sling | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | days | | Following index surgery, up to 7 weeks | | | | ID | Title | Description |
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| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery | Participants ability to return to previous type of work within 12 months post-index surgery was measured by the number of participants work status. Work status was identified as "Not currently employed", "Did not return to work", "Returned to partial, modified, or parttime employment", or "Returned to fulltime employment." The type of work for each work status (excluding "Not currently employed") was then categorized as:
- Very heavy work
- Heavy work
- Medium work
- Light work
- Sedentary work
| Overall number of participants with available data for the treatment and time frame indicated. It was possible for participants to return to partial, modified, or part-time employment, and then return to fulltime employment within the 12 month period. Meaning, multiple responses were allowed. | Posted | | Count of Participants | | Participants | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Time to Return to Driving | Time to return to driving post-index surgery measured in days. | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | days | | Following index surgery, up to 139 days | | | | ID | Title | Description |
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| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Time to Return to Sports | Time to return to sports involving overhead throwing post-index surgery measured in days. | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | days | | Following index surgery, approximately 1 year | | | | ID | Title | Description |
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| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Participants With Progression to Full-Thickness Tear at 12 Months | The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following:
- Tendinosis
- Low-grade Partial Thickness Tear
- High-grade Partial Thickness Tear
- Full-Thickness Tear
- Intact
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Participants With Progression to Full-Thickness Tear at 24 Months | The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following:
- Tendinosis
- Low-grade Partial Thickness Tear
- High-grade Partial Thickness Tear
- Full-Thickness Tear
- Intact
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Participants Percent Filling of Rotator Cuff at 12 Months | The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 12 months post-index surgery as bursal (Yes/No), then categorized as one of the following:
- 0% to < 25%
- 25% to < 50%
- 50% to < 75%
- 75% to <100%
- 100%
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Participants Percent Filling of Rotator Cuff at 24 Months | The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 24 months post-index surgery as bursal (Yes/No), then categorized as one of the following:
- 0% to < 25%
- 25% to < 50%
- 50% to < 75%
- 75% to <100%
- 100%
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Rotator Cuff Tendon Thickness at 12 Months | Rotator cuff tendon thickness in millimeters (mm) at 12 months post-index surgery categorized as:
- Total Thickness (where tendon thickness cannot be differentiated)
- Thickness of Native (where tendon thickness can be differentiated)
- Thickness of New Tissue (where tendon thickness can be differentiated)
- Total Thickness (where tendon thickness can be differentiated)
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | millimeters (mm) | | 12 Months | | | | ID | Title | Description |
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| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Rotator Cuff Tendon Thickness at 24 Months | Rotator cuff tendon thickness in millimeters (mm) at 24 months post-index surgery categorized as:
- Total Thickness (where tendon thickness cannot be differentiated)
- Thickness of Native (where tendon thickness can be differentiated)
- Thickness of New Tissue (where tendon thickness can be differentiated)
- Total Thickness (where tendon thickness can be differentiated)
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | millimeters (mm) | | 24 Months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Participants Goutallier Classification of Rotator Cuff at 12 Months | The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following:
- Grade 1
- Grade 2
- Grade 3
- Grade 4
- Grade 0
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Participants Goutallier Classification of Rotator Cuff at 24 Months | The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following:
- Grade 1
- Grade 2
- Grade 3
- Grade 4
- Grade 0
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Participants Sugaya Score of Rotator Cuff at 12 Months | The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following:
- Type I
- Type II
- Type III
- Type IV
- Type V
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
|
| Secondary | Number of Participants Sugaya Score of Rotator Cuff at 24 Months | The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following:
- Type I
- Type II
- Type III
- Type IV
- Type V
| Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
|
| Secondary | Number of Participants With Revision Surgery | Incidence of revision surgery measured by the number of participants with Revision Surgery (Yes/No) defined as any revision surgery involving the index shoulder for any cause within 24 months post-index surgery. | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Count of Participants | | Participants | | Following index surgery, up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
| |
| Secondary | Aggregate Health Care Utilization Costs | Related health care utilization costs over 12 months post- surgery will be calculated based on health care utilization as reported in the participant diary and/or in the participant's medical records. | Appropriate data not collected to perform analysis as a result of study termination | Posted | | | | | | Following index surgery, up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Operating Room Time (Index Surgery) | Operating time for the index surgery, defined as the time from first incision to wound closure (measured in minutes) as recorded in the operative procedure notes. | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | minutes | | Intra-operative | | | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
| |
| Secondary | Number of Steroid Injections | The number of steroid injections per participant administered to the index shoulder over 12 months post-index surgery as reported in the participant diary and/or in the participant's medical record. | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | injections | | Following index surgery, up to 12 months | injections | injections | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Unscheduled Clinic Visits | The number of unscheduled clinic visits per participant (defined as a return visit to a health care provider for examination/evaluation of the index shoulder) over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record. | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | unscheduled visits | | Following index surgery, up to 12 months | unscheduled visits | unscheduled visits | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of For-Cause Imaging Procedures | The total number of for cause imaging procedures (e.g., MRI or ultrasound) per participant performed on the index shoulder over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | for-cause imaging procedures | | Following index surgery, up to 12 months | for-cause imaging procedures | for-cause imaging procedures | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
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| Secondary | Number of Physiotherapy Sessions | The total number of physiotherapy sessions per participant over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record | Overall number of participants with available data for the treatment and time frame indicated. | Posted | | Mean | Standard Deviation | physiotherapy sessions | | Following index surgery, up to 12 months | physiotherapy sessions | physiotherapy sessions | | ID | Title | Description |
|---|
| OG000 | REGENETEN™ Bioinductive Implant | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons. | | OG001 | Arthroscopic Repair of the High-grade (>50%) Partial-thickness | Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
| |