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

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

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 Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: Double Row; Device: PRFM

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • TRIA Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double Row	Procedure: Double Row
Experimental: Double Row with PRFM	Procedure: Double Row; Device: PRFM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to Function	The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.	Baseline
Return to Function	The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.	6 months
Return to Function	Western Ontario Rotator Cuff Index	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spraspinatus Strength Measurements	Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.	Baseline
MRI	MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear. Higher grades are worse radiographic outcomes.	6 months
Supraspinatus Strength Measurements	Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.	6 months
Supraspinatus Strength Measurements	Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.	24 months
Infraspinatus Strength Measurements	Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.	Baseline
Infraspinatus Strength Measurements	Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.	6 months
Infraspinatus Strength Measurements	Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.	24 months

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: Musculoskeletal Transplant Foundation

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Shoulder pain; Rotator cuff tear; Rotator cuff injury; Shoulder injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 04100-11-C