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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458665
• Other study ID #: BRM-11-01
• Status: Completed
• Phase: N/A
• First received: October 21, 2011
• Last updated: June 16, 2014
• Start date: October 2011

Study information

• Verified date: June 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

medium to large 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No