Assessment of Outcome of Meniscus Repair With or Without Platelet Rich Plasma
Primary Purpose
Cartilage Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meniscus repair for red/white tears without PRP
Meniscus repair with PRP
Sponsored by
About this trial
This is an interventional treatment trial for Cartilage Disease focused on measuring Meniscus, Avascular region, Platelet rich plasma
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for meniscus repair who provide informed consent to participate
Exclusion Criteria:
- Patients scheduled for meniscus repair who refuse to participate
- Presence of a tumor, metastatic disease, active infections, platelet count < 10 5/hl Hgb < 10 g/dl, pregnancy, active breastfeeding, and allergy to Bupivicaine
- Patients with preexisting thrombocytopenia, hypofibrinogenemia, or who are on anti-coagulant therapy, or who have a potential hypersensitivity to bovine products
Sites / Locations
- Cincinnati Sportsmedicine and Orthopaedic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meniscus repair with PRP
Meniscus repair without PRP
Arm Description
Meniscus repair for tears extending into the red/white region with PRP
Outcomes
Primary Outcome Measures
Elimination of pain
Secondary Outcome Measures
Magnetic resonance imaging: T2 mapping, signal changes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00961597
Brief Title
Assessment of Outcome of Meniscus Repair With or Without Platelet Rich Plasma
Official Title
Repair of Human Meniscus Complex Red/White Tears With or Without Platelet-Rich Plasma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sue Barber-Westin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this investigation is to determine the clinical outcome of repair of meniscus tears located in the "red/white" region using a well-known suture technique combined, when indicated, with platelet-rich plasma to enhance healing. The outcome of this operation will be determined in a consecutive group of patients with an established, rigorous knee rating system a minimum of 2 years postoperatively. Results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation using standard plain x-rays and magnetic resonance imaging. The investigators hypothesize that meniscus repairs will significantly reduce tibiofemoral compartment pain and allow for increased knee function and activity levels. The platelet rich plasma adjunct will be used in complex meniscus tears in which a portion of the tear extends into the avascular region classified as either longitudinal, horizontal, or radial. The investigators hypothesize that the healing rate of these repairs will be superior to those previously reported in clinical studies in patients who had the suture repair technique alone.
Detailed Description
There are many published clinical studies of complex meniscus tears in the red/white region with success rates that vary from 57% to 100%. Meniscus repairs that fail in this region usually require subsequent removal, which essentially results in loss of the majority of meniscal function and risk of future disabling osteoarthritis. This study will determine if the addition of platelet rich plasma increases the success rate of complex meniscus repairs of longitudinal, horizontal, or radial tears in the red-white region. The investigators have over two decades of experience with clinical studies of meniscus repairs in patients whose age ranged from 9 to 58 years. Those investigations revealed an average success rate in terms of retention of meniscus tissue of 80%. However, meniscus tears classified as horizontal, radial, double longitudinal, and complex multiplanar had success rates of 71-73% which prompted the need for an adjunct therapeutic measure, such as platelet rich plasma, to increase the healing potential in these cases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Disease
Keywords
Meniscus, Avascular region, Platelet rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meniscus repair with PRP
Arm Type
Experimental
Arm Description
Meniscus repair for tears extending into the red/white region with PRP
Arm Title
Meniscus repair without PRP
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Meniscus repair for red/white tears without PRP
Intervention Description
Same operation as experimental, only without the use of platelet rich plasma.
Intervention Type
Procedure
Intervention Name(s)
Meniscus repair with PRP
Intervention Description
Meniscus repair with platelet rich plasma using vertical divergent suture techniques.
Primary Outcome Measure Information:
Title
Elimination of pain
Time Frame
Minimum 2 years postoperatively
Secondary Outcome Measure Information:
Title
Magnetic resonance imaging: T2 mapping, signal changes
Time Frame
Minimum 2 years postoperative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for meniscus repair who provide informed consent to participate
Exclusion Criteria:
Patients scheduled for meniscus repair who refuse to participate
Presence of a tumor, metastatic disease, active infections, platelet count < 10 5/hl Hgb < 10 g/dl, pregnancy, active breastfeeding, and allergy to Bupivicaine
Patients with preexisting thrombocytopenia, hypofibrinogenemia, or who are on anti-coagulant therapy, or who have a potential hypersensitivity to bovine products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank R Noyes, M.D.
Organizational Affiliation
Cincinnati Sportsmedicine Research and Education Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Sportsmedicine and Orthopaedic Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
12. IPD Sharing Statement
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Assessment of Outcome of Meniscus Repair With or Without Platelet Rich Plasma
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