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

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ClinicalTrials.gov Identifier: NCT01238302
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Rotator Cuff Tear Procedure: Conventional arthroscopic rotator cuff repair Procedure: Arthroscopic rotator cuff repair with PRP

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Actual Study Start Date : July 2009
Primary Completion Date : October 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.



Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries