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

NCT ID: NCT02256891

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Double Row

Double Row

Group Type: EXPERIMENTAL

Double Row

Intervention Type: PROCEDURE

Double Row with PRFM

Double Row with PRFM

Group Type: EXPERIMENTAL

PRFM

Intervention Type: DEVICE

Double Row

Intervention Type: PROCEDURE

Interventions

PRFM

Intervention Type: DEVICE

Double Row

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Musculoskeletal Transplant Foundation

OTHER

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TRIA Orthopaedic Center

Bloomington, Minnesota, United States

Countries

United States

Other Identifiers

04100-11-C

Identifier Type: -

Identifier Source: org_study_id