Full Thickness Rotator Cuff TearNCT01849458
BioFiber Scaffold Post-Market Observational Study
An observational study of Full Thickness Rotator Cuff Tear, run by Stryker Trauma and Extremities at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Full Thickness Rotator Cuff Tear
- What is being tested?
- BioFiber
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2013to Apr 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopedic referral clinic
Who may be able to join
- Patients 18 years of age or older
- Patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair.
- Patients willing and able to comply with the requirements of the study protocol and provide informed consent.
Who cannot join
- Patients with active or latent infection
- Patients with decreased vascularity
- Patients with pathological soft tissue conditions
- Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate
- Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only)
- Participating in a concurrent study that has not been approved for concurrent enrollment by the Clinical Study Manager
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Virginia Sports Medicine and Shoulder Surgery
Charlottesville, Virginia, 22908
Insall Scott Kelly Institute
New York, New York, 10065
About this study
Official title: BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study
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.
Read the detailed description
Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.
- Conditions
- Full Thickness Rotator Cuff Tear
- Being tested
- BioFiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFiberDevice
Also called BioFiber Scaffold, BioFiber-CM Scaffold
Subjects implanted with BioFiber or BioFiber-CM Scaffold
| Study group | Role | What they receive |
|---|---|---|
| BioFiber | Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold Receives: Device: BioFiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Full Thickness Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Brockmeier, MD, Principal investigator, University of VirginiaTimothy Reish, MD, Principal investigator, Insall Scott Kelly InstitutePhilippe Collin, MD, Principal investigator, St. Gregoire, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849458
- Sponsor's protocol ID
- Tornier 2013-1
- Status last verified
- Jun 2017
- First submitted
- 6 May 2013
- Last updated
- 22 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study
- ClinicalTrials.gov ID
- NCT01849458
- Acronym / sponsor ID
- Tornier 2013-1
- Conditions
- Full Thickness Rotator Cuff Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Posted 22 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioFiber | – | Device: BioFiberSubjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopedic referral clinic
Key inclusion criteria (3 listed)
- Patients 18 years of age or older
Key exclusion criteria (6 listed)
- Patients with active or latent infection
- Patients with decreased vascularity
- Patients with pathological soft tissue conditions
- Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate
- Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioFiberAlso: BioFiber Scaffold, BioFiber-CM ScaffoldSubjects implanted with BioFiber or BioFiber-CM Scaffold | Device | BioFiber |
Primary outcome
Number of Participants With Device Associated Adverse Events
Time frame: 12 Months
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.
6 secondary outcomes
Clinical Functional Outcome - Adjusted Constant-Murley Score
Time frame: 6 Months
Clinical Functional Outcome - Adjusted Constant-Murley Score
Time frame: 12 Month
Clinical Functional Outcome - WORC Index
Time frame: 6 Months
Clinical Functional Outcome - WORC Index
Time frame: 12 Months
Number of Study Participants With Re-tears
Time frame: 6 Months
Number of Study Participants With Re-tears
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Brockmeier, MD principal investigator
University of Virginia
Timothy Reish, MD principal investigator
Insall Scott Kelly Institute
Philippe Collin, MD principal investigator
St. Gregoire, France
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Full Thickness Rotator Cuff Tear, run by Stryker Trauma and Extremities at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device Associated Adverse Events (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.