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BioFiber Scaffold Post-Market Observational Study

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ClinicalTrials.gov Identifier: NCT01849458
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Tornier, Inc.

Brief 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.

Condition or disease Intervention/treatment
Full Thickness Rotator Cuff Tear Device: BioFiber

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study
Study Start Date : March 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Group/Cohort Intervention/treatment
BioFiber
Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Device: BioFiber
Subjects implanted with BioFiber or BioFiber-CM Scaffold
Other Names:
  • BioFiber Scaffold
  • BioFiber-CM Scaffold




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Clinical Functional Outcome - Adjusted Constant-Murley Score [ Time Frame: 6 Months ]
    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.

  2. Clinical Functional Outcome - Adjusted Constant-Murley Score [ Time Frame: 12 Month ]
    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.

  3. Clinical Functional Outcome - WORC Index [ Time Frame: 6 Months ]
    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.

  4. Clinical Functional Outcome - WORC Index [ Time Frame: 12 Months ]
    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.

  5. Number of Study Participants With Re-tears [ Time Frame: 6 Months ]
    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. Number of Study Participants With Re-tears [ Time Frame: 12 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Orthopedic referral clinic
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849458


Locations
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United States, New York
Insall Scott Kelly Institute
New York, New York, United States, 10065
United States, Virginia
University of Virginia Sports Medicine and Shoulder Surgery
Charlottesville, Virginia, United States, 22908
France
St. Gregoire
St. Gregoire, France
Sponsors and Collaborators
Tornier, Inc.
Investigators
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Principal Investigator: Stephen Brockmeier, MD University of Virginia
Principal Investigator: Timothy Reish, MD Insall Scott Kelly Institute
Principal Investigator: Philippe Collin, MD St. Gregoire, France

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Responsible Party: Tornier, Inc.
ClinicalTrials.gov Identifier: NCT01849458     History of Changes
Other Study ID Numbers: Tornier 2013-1
First Posted: May 8, 2013    Key Record Dates
Results First Posted: June 22, 2017
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries