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

NCT01458665 | Completed

• 1 other identifier: BRM-11-01
• Study Type: interventional
• Target: 74
• 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 medium to large 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)

• Constant-Murley shoulder score

  The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.

  Postoperative 3months

Study Arms (2)

PRP group

EXPERIMENTAL

Procedure: Arthroscopic rotator cuff repair with PRP

Conventional group

PLACEBO COMPARATOR

Procedure: Conventional arthroscopic rotator cuff repair

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:

• medium to large 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 H. 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: October 21, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

KR (1)