Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00961597
Study type Interventional
Source Cincinnati Sportsmedicine Research and Education Foundation
Contact
Status Withdrawn
Phase N/A
Start date September 2009
Completion date December 2014

See also
  Status Clinical Trial Phase
Recruiting NCT02991300 - BioPoly® RS Partial Resurfacing Patella Registry Study
Not yet recruiting NCT05391841 - Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee
Recruiting NCT04785092 - All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects N/A
Completed NCT02941120 - Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects
Completed NCT02179346 - Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects
Recruiting NCT04537013 - Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee N/A
Not yet recruiting NCT06238947 - Long-term Outcome Evaluation of Patients Undergoing Autologous Chondrocyte Transplantation Delivered on Biomaterial
Active, not recruiting NCT04186208 - Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients