Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical and anatomical outcomes of rotator cuff repair with Platelet-Rich Plasma(PRP) and conventional rotator cuff repair in treatment of large to massive rotator cuff tears. PRP application to arthroscopic rotator cuff repair would accelerate recovery after arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall satisfaction, and enhance structural integrity of repaired tendon.

Official Title
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Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears : A Randomized Controlled Trial

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: Conventional arthroscopic rotator cuff repair
* Procedure: Arthroscopic rotator cuff repair with PRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: large to massive rotator cuff tear as a determined by clinical examination and MR prior to surgery. Exclusion Criteria: previous history of shoulder surgery acute trauma chronic dislocation pyogenic infection rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head showed abnormal serological test results thrombocytopenia (platelets less than 15000 per microliter) had been received anti-platelet medication psychiatric problems that precludes informed consent or inability to read or write other serious problems that preclude participation of the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional group<br> | Procedure: Conventional arthroscopic rotator cuff repair<br>* Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table. The surgical area was prepared and draped with Betadine. Small stab incisions were made in the creation of 4-5 portals as needed. A scope was explored via the arthroscopic portal into the GH joint & subacromial space. Repair of full thickness rotator cuff tear was done with suture anchors. The skin was closed with Nylon or medical staples. Sterile dressing was applied on surgical wound.<br>|
| Experimental: PRP group<br> | Procedure: Arthroscopic rotator cuff repair with PRP<br>* Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table. The surgical area was prepared and draped with Betadine. Small stab incisions were made in the creation of 4-5 portals as needed. A scope was explored via the arthroscopic portal into the GH joint & subacromial space. Repair of full thickness rotator cuff tear was done with suture anchors. After tying sutures of the medial row, PRP gels were applied on the repair site. The lateral row was secured using suture anchors. The skin was closed with Nylon or medical staples. Sterile dressing was applied on surgical wound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| structural integrity of repaired rotator cuff tendon | To evaluate structural outcomes, magnetic resonance(MR)imaging or computed tomography arthrography were used at minimum postoperative 9months. The structural integrity was evaluated using Sugaya's method; type I, sufficient thickness with homogenously low intensity type II, insufficient thickness partial high intensity type III, insufficient thickness without discontinuity (thinned cuff) type IV, presence of minor discontinuity type V, presence of a major discontinuity Type I, II, and III were considered as healed, while type IV, and V were considered as retear. | postoperative 9months |