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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cartilage Disease
• Intervention / Treatment: Procedure: Meniscus repair with PRP; Procedure: Meniscus repair for red/white tears without PRP

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Sportsmedicine and Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Elimination of pain	Minimum 2 years postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Magnetic resonance imaging: T2 mapping, signal changes	Minimum 2 years postoperative

Collaborators and Investigators

• Sponsor: Sue Barber-Westin
• Investigators: Principal Investigator: Frank R Noyes, M.D., Cincinnati Sportsmedicine Research and Education Foundation

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 18, 2009
• First Submitted That Met QC Criteria: August 18, 2009
• First Posted (Estimate): August 19, 2009

Study Record Updates

• Last Update Posted (Estimate): December 11, 2014
• Last Update Submitted That Met QC Criteria: December 10, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Meniscus; Platelet rich plasma; Avascular region
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: MenisPRP-001