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

• ClinicalTrials.gov Identifier: NCT02256891
• Recruitment Status: Completed
• First Posted: October 6, 2014
• Results First Posted: August 9, 2017
• Last Update Posted: August 9, 2017
• Sponsor: HealthPartners Institute
• Collaborator: Musculoskeletal Transplant Foundation
• Information provided by (Responsible Party): HealthPartners Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Tear	Device: PRFM; Procedure: Double Row	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Arthroscopic Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique: A Randomized Blinded Outcomes Study
• Study Start Date: July 2011
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Double Row; Double Row	Procedure: Double Row
Experimental: Double Row with PRFM; Double Row with PRFM	Device: PRFM; Procedure: Double Row

Outcome Measures

Primary Outcome Measures :

1. Return to Function [ Time Frame: Baseline ]
   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.
2. Return to Function [ Time Frame: 6 months ]
   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.
3. Return to Function [ Time Frame: 24 months ]
   Western Ontario Rotator Cuff Index

Other Outcome Measures:

1. Spraspinatus Strength Measurements [ Time Frame: Baseline ]
   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.
2. MRI [ Time Frame: 6 months ]

   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.

3. Supraspinatus Strength Measurements [ Time Frame: 6 months ]
   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.
4. Supraspinatus Strength Measurements [ Time Frame: 24 months ]
   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.
5. Infraspinatus Strength Measurements [ Time Frame: Baseline ]
   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. Infraspinatus Strength Measurements [ Time Frame: 6 months ]
   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.
7. Infraspinatus Strength Measurements [ Time Frame: 24 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

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

Contacts and Locations

Locations

United States, Minnesota

TRIA Orthopaedic Center

Bloomington, Minnesota, United States, 55431

Sponsors and Collaborators

HealthPartners Institute

Musculoskeletal Transplant Foundation

More Information

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT02256891
• Other Study ID Numbers: 04100-11-C
• First Posted: October 6, 2014
• Results First Posted: August 9, 2017
• Last Update Posted: August 9, 2017
• Last Verified: October 2015

Keywords provided by HealthPartners Institute:

Rotator cuff tear; Rotator cuff injury; Shoulder pain; Shoulder injury

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries