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

NCT02256891 | Completed Phase 4 Results DMC

• 1 other identifier: 04100-11-C
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Spraspinatus Strength Measurements

  Baseline

• MRI

  6 months

• Supraspinatus Strength Measurements

  6 months

Study Arms (2)

Double Row

EXPERIMENTAL

Double Row

Procedure: Double Row

Double Row with PRFM

EXPERIMENTAL

Double Row with PRFM

Device: PRFM; Procedure: Double Row

Interventions

PRFM DEVICE

Double Row with PRFM

Double Row PROCEDURE

Double Row; Double Row with PRFM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (1)

TRIA Orthopaedic Center

Bloomington, Minnesota, 55431, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain; Shoulder Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

A disadvantage is the majority of the tears are small or medium sized. These have a higher intrinsic healing and as such may not require platelet augmentation to afford a successful outcome.

Results Point of Contact

• Title: Michael Walsh
• Organization: Health Partners

michael.walsh@tria.com

(952) 831-8742

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: October 6, 2014
• Study Start: July 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 9, 2017
• Results First Posted: August 9, 2017

Record last verified: 2015-10

Locations

US (1)