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

NCT ID: NCT00961597

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Cartilage Disease

Keywords

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Meniscus Avascular region Platelet rich plasma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meniscus repair with PRP

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

Group Type EXPERIMENTAL

Meniscus repair with PRP

Intervention Type PROCEDURE

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

Meniscus repair without PRP

Group Type ACTIVE_COMPARATOR

Meniscus repair for red/white tears without PRP

Intervention Type PROCEDURE

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

Interventions

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Meniscus repair for red/white tears without PRP

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

Intervention Type PROCEDURE

Meniscus repair with PRP

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sue Barber-Westin

OTHER

Sponsor Role lead

Responsible Party

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Sue Barber-Westin

Director Clinical Studies

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Frank R Noyes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Sportsmedicine Research and Education Foundation

Locations

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Cincinnati Sportsmedicine and Orthopaedic Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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MenisPRP-001

Identifier Type: -

Identifier Source: org_study_id