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

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: Conventional arthroscopic rotator cuff repair; Procedure: Arthroscopic rotator cuff repair with PRP

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
structural integrity of repaired rotator cuff tendon	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.	postoperative 9months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (Estimate): November 10, 2010

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: BRM-10-03