Back to resultsArthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive 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
About this trial
This is an interventional treatment trial for Rotator Cuff Tear
Eligibility Criteria
Inclusion Criteria:
large to massive 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
Placebo Comparator
Experimental
Arm Label
Conventional group
PRP group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01238302
First Posted
November 8, 2010
Last Updated
February 23, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01238302
Brief Title
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears
Official Title
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (Actual)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)
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 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.
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
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional group
Arm Type
Placebo Comparator
Arm Title
PRP group
Arm Type
Experimental
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
structural integrity of repaired rotator cuff tendon
Description
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.
Time Frame
postoperative 9months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
large to massive 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 Hyunchul 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
Learn more about this trial
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears
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