The goal of this observational study is to evaluate the clinical and radiographic outcomes of the biological enhancement of the arthroscopic rotator cuff repair with stem cells from the acromial bursa and PRP in individuals who undergo arthroscopic cuff repair The main question it aims to answer is:
Do the stems cells from the acromial bursa and PRP promote healing and produce better results in arthroscopic cuff repair? Researchers will compare this population to three others the first do bnot receive any biological enchancement, the second receive only stem cells and the third receive only PRP to see if there are any differences.
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Parallel
Subacromial Bursa Tissue Reimplantation
Biological/VaccineAutologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair.
Arthroscopic Rotator Cuff Repair
Procedure/SurgeryStandard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
Platelet-Rich Plasma (PRP) Injections
Biological/VaccineAutologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion.
Normal Saline (0.9% NaCl)
Other interventionThree milliliters of sterile normal saline applied at the bone-tendon interface immediately after arthroscopic rotator cuff repair as placebo comparator.
Functional Outcome Assessed by Constant-Murley Score and ASES Score
The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments evaluating pain, daily activities, and shoulder function, with higher scores indicating better clinical outcomes.
Rotator Cuff Tendon Integrity Assessed by MRI (Sugaya Classification)
Tendon integrity will be evaluated using magnetic resonance imaging (MRI) at 12 months postoperatively. Repair integrity will be classified according to the Sugaya classification system and categorized to assess healing or re-tear.
Pain Intensity Assessed by Numeric Rating Scale (NRS)
Postoperative pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 3, 6, and 12 months postoperatively.
Health-Related Quality of Life Assessed by SF-12
Quality of life will be evaluated using the 12-Item Short Form Health Survey (SF-12) at 3, 6, and 12 months postoperatively. The questionnaire provides physical and mental health composite scores.
Patient Satisfaction
Patient satisfaction will be assessed using a Numeric Rating Scale from 0 to 10 at 3, 6, and 12 months postoperatively, with higher scores indicating greater satisfaction.
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National and Kapodistrian University of Athens
Lead sponsor
Athens Medical Center
Collaborator
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