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

Cartilage Disease Clinical Trial

Official title:

Repair of Human Meniscus Complex Red/White Tears With or Without Platelet-Rich Plasma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00961597
• Other study ID #: MenisPRP-001
• Status: Withdrawn
• Phase: N/A
• First received: August 18, 2009
• Last updated: December 10, 2014
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Cincinnati Sportsmedicine Research and Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cartilage Disease
• Cartilage Diseases

Intervention

Procedure:
• Meniscus repair for red/white tears without PRP
Same operation as experimental, only without the use of platelet rich plasma.
• Meniscus repair with PRP
Meniscus repair with platelet rich plasma using vertical divergent suture techniques.

Locations

Country	Name	City	State
United States	Cincinnati Sportsmedicine and Orthopaedic Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Sue Barber-Westin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elimination of pain		Minimum 2 years postoperatively	No
Secondary	Magnetic resonance imaging: T2 mapping, signal changes		Minimum 2 years postoperative	No