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The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioFiber | Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioFiber | Device | Subjects implanted with BioFiber or BioFiber-CM Scaffold |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device Associated Adverse Events | The primary objective is to report the number of participants with device associated adverse events. Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Functional Outcome - Adjusted Constant-Murley Score | Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome. |
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Inclusion Criteria:
Patients 18 years of age or older
Exclusion Criteria:
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Orthopedic referral clinic
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Brockmeier, MD | University of Virginia | Principal Investigator |
| Timothy Reish, MD | Insall Scott Kelly Institute | Principal Investigator |
| Philippe Collin, MD | St. Gregoire, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insall Scott Kelly Institute | New York | New York | 10065 | United States | ||
| University of Virginia Sports Medicine and Shoulder Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | BioFiber Scaffold | Single arm of subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | BioFiber | Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Device Associated Adverse Events | The primary objective is to report the number of participants with device associated adverse events. Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device. | Posted | Count of Participants | Participants | 12 Months |
|
|
12 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BioFiber | Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Left shoulder deep abscess and suspected septic arthritis of glenohumeral joint. Not related to device, possible relatedness to procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clot | Vascular disorders | Focal 1 cm superficial clot in mid left basilica vein. Reported as not related to device and possibly related to procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcela Bravo | Tornier Inc. | 9526837481 | marcela.bravo@tornier.com |
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| 6 Months |
| Clinical Functional Outcome - Adjusted Constant-Murley Score | Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome. | 12 Month |
| Clinical Functional Outcome - WORC Index | Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life. | 6 Months |
| Clinical Functional Outcome - WORC Index | Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life. | 12 Months |
| Number of Study Participants With Re-tears | Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear. | 6 Months |
| Number of Study Participants With Re-tears | Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear. | 12 Months |
| Charlottesville |
| Virginia |
| 22908 |
| United States |
| St. Gregoire | Saint-Grégoire | France |
| Arms |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 | Participants |
|
|
|
| Secondary | Clinical Functional Outcome - Adjusted Constant-Murley Score | Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome. | 50 Participants | Posted | Mean | Standard Deviation | scores on a scale | 6 Months |
|
|
|
|
| Secondary | Clinical Functional Outcome - Adjusted Constant-Murley Score | Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome. | Posted | Mean | Standard Deviation | scores on a scale | 12 Month |
|
|
|
|
| Secondary | Clinical Functional Outcome - WORC Index | Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life. | One subject is missing data for this outcome measure thus a total of 49 subjects were analyzed in this section. | Posted | Mean | Standard Deviation | Percentage of WORC Index | 6 Months |
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|
|
| Secondary | Clinical Functional Outcome - WORC Index | Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life. | Posted | Mean | Standard Deviation | Percentage of WORC Index | 12 Months |
|
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|
|
| Secondary | Number of Study Participants With Re-tears | Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| Secondary | Number of Study Participants With Re-tears | Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| 3 |
| 50 |
| 1 |
| 50 |
|
| Stroke | Vascular disorders | Acute ischemic Stroke, multiple punctate infarcts in the first posterior, frontal and parietal lobes. Not related to device, not related to procedure. |
|
| Deep Vein Thrombosis | Vascular disorders | Deep Vein Thrombosis/pulmonary embolism. Not related to device, possible relatedness to procedure. |
|
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