An observational study in Full Thickness Rotator Cuff Tear, sponsored by Stryker Trauma and Extremities. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-22.
Sponsored by Stryker Trauma and Extremities · Observational
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 50 is below the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Orthopedic referral clinic
Patients 18 years of age or older
Exclusion Criteria:
Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Device: BioFiber
Subjects implanted with BioFiber or BioFiber-CM Scaffold
Also known as: BioFiber Scaffold, BioFiber-CM Scaffold
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.
Time frame: 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 Months
| Milestone | BioFiber Scaffold |
|---|---|
| Started | 50 |
| 6 months follow-up | 50 |
| Completed | 46 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
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.
| Participants | BioFiber |
|---|---|
| Number of Participants With Device Associated Adverse Events | 4 |
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.
| scores on a scale | BioFiber |
|---|---|
| Clinical Functional Outcome - Adjusted Constant-Murley Score | 93.4 ± 17.5 |
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.
| scores on a scale | BioFiber |
|---|---|
| Clinical Functional Outcome - Adjusted Constant-Murley Score | 97.1 ± 16.1 |
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.
| Percentage of WORC Index | BioFiber |
|---|---|
| Clinical Functional Outcome - WORC Index | 80.7 ± 18.9 |
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.
| Percentage of WORC Index | BioFiber |
|---|---|
| Clinical Functional Outcome - WORC Index | 86.8 ± 16.3 |
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.
| Participants | BioFiber |
|---|---|
| Number of Study Participants With Re-tears | 2 |
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.
| Participants | BioFiber |
|---|---|
| Number of Study Participants With Re-tears | 2 |
Collected over 12 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BioFiber | — | 3/50 (6%) | 1/50 (2%) |
| Event | BioFiber |
|---|---|
| InfectionInfections and infestations | 1/50 |
| StrokeVascular disorders | 1/50 |
| Deep Vein ThrombosisVascular disorders | 1/50 |
| Event | BioFiber |
|---|---|
| ClotVascular disorders | 1/50 |
| Age, Continuous(years) | BioFiber |
|---|---|
| Mean | 61.2 ± 6.9 |
| Sex: Female, Male(Participants) | BioFiber |
|---|---|
| Female | 27 |
| Male | 23 |
| Region of Enrollment(participants) | BioFiber |
|---|---|
| United States | 39 |
| France | 11 |
| BMI(kg/m^2) | BioFiber |
|---|---|
| Mean | 27.9 ± 7 |
Plan to share: No
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Stryker Trauma and Extremities