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

NCT01238302 | Completed

• 1 other identifier: BRM-10-03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional group

PLACEBO COMPARATOR

Procedure: Conventional arthroscopic rotator cuff repair

PRP group

EXPERIMENTAL

Procedure: Arthroscopic rotator cuff repair with PRP

Interventions

Conventional arthroscopic rotator cuff repair PROCEDURE

* 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.

Conventional group

Arthroscopic rotator cuff repair with PRP PROCEDURE

* 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.

PRP group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, SMG-SNU Boramae Medical Center.

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 10, 2010
• Study Start: July 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

KR (1)