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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hyunchul Jo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01458665
First received: October 21, 2011
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose
  • 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.

Condition Intervention
Rotator Cuff Tear
 Procedure: Conventional arthroscopic rotator cuff repair
Procedure: Arthroscopic rotator cuff repair with PRP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears: A Randomized Controlled Trial

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 74
Study Start Date: October 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRP group 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.
Placebo Comparator: Conventional group 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458665

Locations
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
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Hyunchul Jo, Assistant Professor, SMG-SNU Boramae Medical Center, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01458665     History of Changes
Other Study ID Numbers: BRM-11-01
Study First Received: October 21, 2011
Last Updated: March 14, 2013
Health Authority: Korea: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013