Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Intervention: PRFM; Double Row
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotator cuff tear; Rotator cuff injury; Shoulder pain; Shoulder injury

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