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

Rotator Cuff Tear Clinical Trial

— RCRPRFM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256891
• Other study ID #: 04100-11-C
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2014
• Last updated: August 24, 2016
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Device:
• PRFM

Procedure:
• Double Row

Locations

Country	Name	City	State
United States	TRIA Orthopaedic Center	Bloomington	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Strength Measurements	Strength measurements of supraspinatus and infraspinatus.	Baseline	No
Other	MRI		6 months	No
Other	Strength Measurements	Strength measurements of supraspinatus and infraspinatus.	6 months	No
Other	Strength Measurements	Strength measurements of supraspinatus and infraspinatus.	24 months	No
Primary	Return to function	Western Ontario Rotator Cuff Index Simple shoulder test	Baseline	No
Primary	Return to function	Western Ontario Rotator Cuff Index Simple shoulder test	6 months	No
Primary	Return to function	Western Ontario Rotator Cuff Index Simple shoulder test	24 months	No

External Links

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