CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 97 enrolled
Drug / intervention
PRFM +1 moredevice
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/NCT02256891
NCT02256891Phase 4Completed

Arthroscopic Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique: A Randomized Blinded Outcomes Study

HealthPartners Institute·interventional·Posted Oct 6, 2014·Updated Aug 9, 2017

In Brief

A Phase 4 clinical trial evaluating PRFM and Double Row for Rotator Cuff Tear. Completed, enrolled 97 participants across 1 site.

Detailed Summary

This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques. One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other technique is the standard double row repairs utilizing medial and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is hypothesized that patients undergoing the surgery with the PRFM will report a higher quality of life than the patients that do not receive this treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2014
Enrollment StartJul 1, 2011
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.7 years ago

Interventions

PRFMdevice

Double Rowprocedure