Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears
- 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.
|Rotator Cuff Tear||Procedure: Conventional arthroscopic rotator cuff repair Procedure: Arthroscopic rotator cuff repair with PRP|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears : A Randomized Controlled Trial|
- structural integrity of repaired rotator cuff tendon [ Time Frame: 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.
|Actual Study Start Date:||July 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Conventional group||
Procedure: Conventional arthroscopic rotator cuff repair
|Experimental: PRP group||
Procedure: Arthroscopic rotator cuff repair with PRP
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238302
|Korea, Republic of|
|Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine|
|Seoul, Korea, Republic of, 156-707|
|Principal Investigator:||Chris Hyunchul Jo, M.D., Ph.D||Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine|