Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears
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|ClinicalTrials.gov Identifier: NCT01238302|
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : February 27, 2017
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Procedure: Conventional arthroscopic rotator cuff repair Procedure: Arthroscopic rotator cuff repair with PRP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears : A Randomized Controlled Trial|
|Actual Study Start Date :||July 2009|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
|Placebo Comparator: Conventional group||
Procedure: Conventional arthroscopic rotator cuff repair
|Experimental: PRP group||
Procedure: Arthroscopic rotator cuff repair with PRP
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|