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

Not Applicable

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Arthroscopic rotator cuff repair with PRP; Procedure: Conventional arthroscopic rotator cuff repair

• Registration Number: NCT01458665
• 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 medium to large 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Primary Completion: 2013-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-16
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

medium to large rotator cuff tear as a determined by clinical examination and MR prior to surgery.

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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

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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
Constant-Murley shoulder score	Postoperative 3months	The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.

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