Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears
- Conditions
- Rotator Cuff Tear
- Interventions
- Procedure: Arthroscopic rotator cuff repair with PRPProcedure: Conventional arthroscopic rotator cuff repair
- Registration Number
- NCT01238302
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
large to massive rotator cuff tear as a determined by clinical examination and MR prior to surgery.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRP group Arthroscopic rotator cuff repair with PRP - Conventional group Conventional arthroscopic rotator cuff repair -
- Primary Outcome Measures
Name Time Method structural integrity of repaired rotator cuff tendon postoperative 9months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
🇰🇷Seoul, Korea, Republic of