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

NCT00961597 | Withdrawn DMC

• 1 other identifier: MenisPRP-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cartilage Disease

Keywords

Meniscus; Avascular region; Platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• Elimination of pain

  Minimum 2 years postoperatively

Secondary Outcomes (1)

• Magnetic resonance imaging: T2 mapping, signal changes

  Minimum 2 years postoperative

Study Arms (2)

Meniscus repair with PRP

EXPERIMENTAL

Meniscus repair for tears extending into the red/white region with PRP

Procedure: Meniscus repair with PRP

Meniscus repair without PRP

ACTIVE COMPARATOR

Procedure: Meniscus repair for red/white tears without PRP

Interventions

Meniscus repair for red/white tears without PRP PROCEDURE

Same operation as experimental, only without the use of platelet rich plasma.

Meniscus repair without PRP

Meniscus repair with PRP PROCEDURE

Meniscus repair with platelet rich plasma using vertical divergent suture techniques.

Meniscus repair with PRP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for meniscus repair who provide informed consent to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Sue Barber-Westin: lead

Study Sites (1)

Cincinnati Sportsmedicine and Orthopaedic Center

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Frank R Noyes, M.D.

  Cincinnati Sportsmedicine Research and Education Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Clinical Studies

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (1)