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Assessment of Outcome of Meniscus Repair With or Without Platelet Rich Plasma

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Cincinnati Sportsmedicine Research and Education Foundation
ClinicalTrials.gov Identifier:
NCT00961597
First received: August 18, 2009
Last updated: September 27, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention
Cartilage Disease
 Procedure: Meniscus repair for red/white tears without PRP
Procedure: Meniscus repair with PRP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repair of Human Meniscus Complex Red/White Tears With or Without Platelet-Rich Plasma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cincinnati Sportsmedicine Research and Education Foundation:

Primary Outcome Measures:
  • Elimination of pain [ Time Frame: Minimum 2 years postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Magnetic resonance imaging: T2 mapping, signal changes [ Time Frame: Minimum 2 years postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meniscus repair with PRP
Meniscus repair for tears extending into the red/white region with PRP
 Procedure: Meniscus repair with PRP
Meniscus repair with platelet rich plasma using vertical divergent suture techniques.
Active Comparator: Meniscus repair without PRP Procedure: Meniscus repair for red/white tears without PRP
Same operation as experimental, only without the use of platelet rich plasma.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961597

Locations
United States, Ohio
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
Cincinnati Sportsmedicine Research and Education Foundation
Investigators
Principal Investigator: Frank R Noyes, M.D. Cincinnati Sportsmedicine Research and Education Foundation
  More Information

No publications provided

Responsible Party: Frank R. Noyes, M.D., President and Medical Director, Cincinnati Sportsmedicine Research and Education Foundation
ClinicalTrials.gov Identifier: NCT00961597     History of Changes
Other Study ID Numbers: MenisPRP-001
Study First Received: August 18, 2009
Last Updated: September 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Cincinnati Sportsmedicine Research and Education Foundation:
Meniscus
Avascular region
Platelet rich plasma

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013