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Clinical Trials/NCT01238302
NCT01238302
Completed
Not Applicable

Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears : A Randomized Controlled Trial

Seoul National University Hospital1 site in 1 country48 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Tear
Sponsor
Seoul National University Hospital
Enrollment
48
Locations
1
Primary Endpoint
structural integrity of repaired rotator cuff tendon
Status
Completed
Last Updated
9 years ago

Overview

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 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.
Registry
clinicaltrials.gov
Start Date
July 2009
End Date
December 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyunchul Jo

Assistant Professor, SMG-SNU Boramae Medical Center.

Seoul National University Hospital

Eligibility 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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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