Clinical trial NCT02256891: Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rotator Cuff Tear
Keywords: Rotator cuff tear
Rotator cuff injury
Shoulder pain
Shoulder injury
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Musculoskeletal Transplant Foundation
First posted: 2014-10-06
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: Return to Function
timeFrame: Baseline
measure: Return to Function
timeFrame: 6 months
measure: Return to Function
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: Spraspinatus Strength Measurements
timeFrame: Baseline
measure: MRI
timeFrame: 6 months
measure: Supraspinatus Strength Measurements
timeFrame: 6 months
measure: Supraspinatus Strength Measurements
timeFrame: 24 months
measure: Infraspinatus Strength Measurements
timeFrame: Baseline
measure: Infraspinatus Strength Measurements
timeFrame: 6 months
measure: Infraspinatus Strength Measurements
timeFrame: 24 months
Locations:
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
Study officials:
References: