BioFiber Scaffold Post-Market Observational Study

Full Thickness Rotator Cuff Tear Clinical Trial

Official title:

BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849458
• Other study ID #: Tornier 2013-1
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: June 20, 2017
• Start date: March 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2017
• Source: Tornier, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Full Thickness Rotator Cuff Tear

Intervention

Device:
• BioFiber
Subjects implanted with BioFiber or BioFiber-CM Scaffold

Locations

Country	Name	City	State
France	St. Gregoire	St. Gregoire
United States	University of Virginia Sports Medicine and Shoulder Surgery	Charlottesville	Virginia
United States	Insall Scott Kelly Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tornier, Inc.

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 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.	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.	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.	6 Months
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.	12 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.	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.	12 Months