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

Sponsor

Sue Barber-Westin (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00961597

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cartilage Disease	Procedure: Meniscus repair for red/white tears without PRP Procedure: Meniscus repair with PRP	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Elimination of pain [Minimum 2 years postoperatively]

Secondary Outcome Measures

Magnetic resonance imaging: T2 mapping, signal changes [Minimum 2 years postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Sportsmedicine and Orthopaedic Center	Cincinnati	Ohio	United States	45242

Sponsors and Collaborators

Sue Barber-Westin

Investigators

Principal Investigator: Frank R Noyes, M.D., Cincinnati Sportsmedicine Research and Education Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sue Barber-Westin, Director Clinical Studies, Cincinnati Sportsmedicine Research and Education Foundation

ClinicalTrials.gov Identifier:

NCT00961597

Other Study ID Numbers:

MenisPRP-001

First Posted:

Aug 19, 2009

Last Update Posted:

Dec 11, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Sue Barber-Westin, Director Clinical Studies, Cincinnati Sportsmedicine Research and Education Foundation

Meniscus

Avascular region

Platelet rich plasma

Additional relevant MeSH terms:

Cartilage Diseases

Study Results

No Results Posted as of Dec 11, 2014