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

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Conventional arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair with PRP
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRP group

Conventional group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2011
Last Updated
June 16, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01458665
Brief Title
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears
Official Title
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Experimental
Arm Title
Conventional group
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Conventional arthroscopic rotator cuff repair
Intervention Description
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
Intervention Name(s)
Arthroscopic rotator cuff repair with PRP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Constant-Murley shoulder score
Description
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.
Time Frame
Postoperative 3months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris H. Jo, M.D., Ph.D
Organizational Affiliation
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

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

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