CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
BioFiberdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01849458
NCT01849458N/ACompleted
CompareCT.gov

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

Stryker Trauma and Extremities·observational·Posted May 8, 2013·Updated Jun 22, 2017

In Brief

An observational study evaluating BioFiber for Full Thickness Rotator Cuff Tear. Completed, enrolled 50 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsFull Thickness Rotator Cuff Tear
CountriesFrance, United States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 8, 2013
Enrollment StartMar 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.2 years ago

Interventions

BioFiberdevice

Subjects implanted with BioFiber or BioFiber-CM Scaffold