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

This study is currently recruiting participants.
Verified October 2011 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Hyunchul Jo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01458665
First received: October 21, 2011
Last updated: October 24, 2011
Last verified: October 2011
History of Changes

October 21, 2011
October 24, 2011
October 2011
October 2013   (final data collection date for primary outcome measure)
Constant-Murley shoulder score [ Time Frame: Postoperative 3months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01458665 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears: A Randomized Controlled Trial
  • 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.
 
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Rotator Cuff Tear
  • Procedure: Conventional arthroscopic rotator cuff repair
    • 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.
  • Procedure: Arthroscopic rotator cuff repair with PRP
    • 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.
  • Experimental: PRP group
    Intervention: Procedure: Arthroscopic rotator cuff repair with PRP
  • Placebo Comparator: Conventional group
    Intervention: Procedure: Conventional arthroscopic rotator cuff repair
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
74
 
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • full-thickness rotator cuff tear
  • tear size: medium to large
  • arthroscopic repair
  • no abnormal finding on preoperative serological test

Exclusion Criteria:

  • full-thickness rotator cuff tears treated with an open technique, debridement only, or arthroplasty
  • partial-thickness rotator cuff tears
  • pyogenic arthritis
  • glenohumeral joint arthritis
  • revision surgery
  • acute trauma evidence including fracture or dislocation of the shoulder joint
  • abnormal findings on preoperative serological test
  • taking antiplatelet therapy
Both
45 Years to 85 Years
No
 
Korea, Republic of
 
NCT01458665
BRM-11-01
No
Hyunchul Jo, Seoul National University Hospital
Seoul National University Hospital
 
Principal Investigator: Chris H. Jo, M.D., Ph.D Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul National University Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP