Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique

Phase 4

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Double Row; Device: PRFM

• Registration Number: NCT02256891
• Lead Sponsor: HealthPartners Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-06
• Status Verified: 2015-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2017-01-24
• Results First Submitted QC: 2017-07-11
• Last Update Submitted: 2017-07-11
• Results First Posted: 2017-08-09
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Evidence of a rotator cuff tear as determined by clinical examination and diagnostic imaging (MRI)
• Patient undergoes arthroscopic rotator cuff repair
• Age 18 or older

Exclusion Criteria

Pre-operative exclusion criteria

• Patient has had a previous arthroscopic rotator cut repair
• A previous diagnosis of Rheumatoid Arthritis
• Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder,
• Evidence of significant rotator cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
• Medical device that would exclude the patient from having a MRI, including a pacemaker, cardiac defibrillator, aneurysm clips, carotid artery clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, or ear implant.
• Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
• Inability to speak or read English
• Psychiatric illness that precludes informed consent.
• Pregnant patients.
• Age 17 or younger
• Unwillingness to be followed for 2 years.
• Bilateral Rotator cuff tear confirmed by clinical exam and MRI
• Patients enrolled in the study who demonstrate retear on clinical exam and MRI, then elect for a repeat surgery.

Intra-operative exclusion criteria (Note: This information will be collected during the chart audit and patients will be excluded from the study at that time.)

• Irreparable cuff tears or tears extending into the subscapularis or teres minor
• Isolated teres minor or subscapularis tears.
• Inelastic and immobile tendon which cannot be advanced to articular margin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double Row	Double Row	Double Row
Double Row with PRFM	PRFM	Double Row with PRFM
Double Row with PRFM	Double Row	Double Row with PRFM

Primary Outcome Measures

Name	Time	Method
Return to Function	24 months	Western Ontario Rotator Cuff Index

Trial Locations

Locations (1)

TRIA Orthopaedic Center; 🇺🇸 Bloomington, Minnesota, United States