BioFiber Scaffold Post-Market Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Full Thickness Rotator Cuff Tear
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • St. Gregoire, France
    • St. Gregoire
• United States
  • New York
    • New York, New York, United States, 10065
      • Insall Scott Kelly Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Sports Medicine and Shoulder Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Orthopedic referral clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 6, 2013
• First Submitted That Met QC Criteria: May 6, 2013
• First Posted (Estimate): May 8, 2013

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: Tornier 2013-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO