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

NCT ID: NCT01458665

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PRP group

Group Type: EXPERIMENTAL

Arthroscopic rotator cuff repair with PRP

Intervention Type: 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.

Conventional group

Group Type: PLACEBO_COMPARATOR

Conventional arthroscopic rotator cuff repair

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyunchul Jo

Assistant Professor, SMG-SNU Boramae Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris H. Jo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BRM-11-01

Identifier Type: -

Identifier Source: org_study_id