Clinical trial NCT00961597: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Cartilage Disease
Keywords: Meniscus
Avascular region
Platelet rich plasma
Lead sponsor: Cincinnati Sportsmedicine Research and Education Foundation
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Elimination of pain
timeFrame: Minimum 2 years postoperatively
Secondary outcomes:
measure: Magnetic resonance imaging: T2 mapping, signal changes
timeFrame: Minimum 2 years postoperative
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Sportsmedicine and Orthopaedic Center
state: Ohio
Study officials:
affiliation: Cincinnati Sportsmedicine Research and Education Foundation
name: Frank R Noyes, M.D.
role: PRINCIPAL_INVESTIGATOR
References: