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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyunchul Jo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01238302
First received: November 8, 2010
Last updated: March 11, 2013
Last verified: March 2013
  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 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 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 Large to Massive Tears : A Randomized Controlled Trial

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • structural integrity of repaired rotator cuff tendon [ Time Frame: postoperative 9months ] [ Designated as safety issue: No ]

    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.



Enrollment: 48
Study Start Date: July 2009
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

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

Inclusion Criteria:

large to massive 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238302

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 Hyunchul 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: NCT01238302     History of Changes
Other Study ID Numbers: BRM-10-03
Study First Received: November 8, 2010
Last Updated: March 11, 2013
Health Authority: Korea: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014