Platelet Rich Plasma Study With Meniscal Repair

April 18, 2016 updated by: Fraser Orthopaedic Research Society

Prospective, Double Blind, Randomized Trial: Meniscal Repair With or Without Augmentation Utilizing Platelet Rich Plasma.

This study will compare meniscal healing with or without platelet rich plasma. The assessments will include validated, disease specific, patient oriented outcome measures, MRI arthrogram (MRA). Results of this study will help ascertain whether PRP improves meniscal healing rates.

Null Hypothesis: There is no difference in meniscal healing with or without the use of PRP.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The integrity of the meniscus is pivotal to the distribution of joint reaction forces and shock absorption across the knee and meniscal damage can lead to secondary degenerative joint disease. This has lead to treatments directed towards repairing and preserving the meniscus to alter the progression of joint degeneration. Although success rates of meniscal repair are greater when performed in association with anterior cruciate reconstruction, healing rates remain in the 70-80% range for isolated repairs.

Therefore, techniques such as the use of fibrin clots, trephining and rasping of the tissues, have been incorporated to improve healing results of meniscal repair. There has been a surge of enthusiasm for the use of Platelet Rich Plasma (PRP) to improve healing rates of soft tissue injuries. Therefore, it may be reasonable to surmise that applying blood products, such as thrombin and platelet rich plasma, to the meniscal repair bed may induce more complete and possibly faster healing.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Port Moody, British Columbia, Canada, V3H 3W9
        • Eagle Ridge Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • complete vertical longitudinal tear > 10 mm in length
  • tear located in the vascular portion of the meniscus, classified as either red-red or red-white zones
  • a stable knee, or a knee that is stabilized with a concurrent ACL reconstruction
  • unstable peripheral tear that can be displaced toward center of joint
  • single tear of the medial and/or lateral meniscus
  • skeletally mature patients 18-60 years of age

Exclusion Criteria:

  • associated significant ligament instability: Grade III MCL, Grade III PCL
  • discoid meniscus
  • ACL deficient knee
  • Outerbridge Grade III or IV cartilage changes on arthroscopy in the involved compartment
  • Significant degenerative changes on radiographs (Kellgren Lawrence >/= Grade III)
  • Associated osteochondral defect that requires treatment
  • Inflammatory arthropathy (e.g. rheumatoid arthritis)
  • Non repairable meniscus (ie white zone, irreducible meniscus)
  • Degenerative meniscus or presence of CPP crystals in meniscus
  • Underlying bleeding disorder or coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With PRP
Standardized meniscal repair with PRP (platelet rich plasma) in the meniscal healing bed.
Procedure: With PRP
Following meniscal repair, PRFM will be delivered arthroscopically into the tear site using a portal skid, arthroscopic canula and arthroscopic atraumatic tissue grasper into the interface of the repair site.
Other Names:
  • Platelet Rich Fibrin Matrix (PRFM)
Active Comparator: Without PRP
Standardized meniscal repair without PRP (platelet rich plasma).
Procedure: Without PRP
Standard of care meniscal repair without augmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRA (magnetic resonance imaging arthrography
Time Frame: 6 months
The primary outcome measures will be assessment of meniscal healing integrity using magnetic resonance imaging arthrography six months post repair.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMET - Western Ontario Meniscal Outcome Measure
Time Frame: Baseline, 3 months, 6 months 12 months

The WOMET is a disease-specific validated tool designed to evaluate HRQOL (Health Related Quality of Life) in patients with meniscal pathology (meniscal tears or in patients who have undergone meniscal repair or resection). In this subset of patients with meniscal pathology, the WOMET has been found to be reliable, valid and responsive.

The WOMET has 16 items including the domains of physical symptoms, sports/recreation/work/lifestyle, and emotions. It demonstrated adequate content and construct validity when compared with other measures. Test-retest reliability was assessed and was found to be high, with an intraclass correlation coefficient of 0.833.
Baseline, 3 months, 6 months 12 months
VAS Pain Score - Visual Analog Scale
Time Frame: Baseline, Post-op Day 1, 6 weeks
Pain Visual Analog Scale.
Baseline, Post-op Day 1, 6 weeks
Range of motion
Time Frame: 6 weeks, 3 months, 6 months, 12 months
Knee range of motion measurements.
6 weeks, 3 months, 6 months, 12 months
Tegner Score
Time Frame: Baseline, 3, 6 and 12 months post treatment
Return to pre injury activity level as measured by the Tegner Score.
Baseline, 3, 6 and 12 months post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Second look arthroscopy
Time Frame: if applicable
If a second look arthroscopy is performed, the status of the meniscus (healed or not healed) will be compared to the MRA findings. Second look arthroscopy will be performed on subjects with clinical indication of a failed meniscal repair. Clinical indications of failed meniscus repair include persistent pain and symptoms or MRA positive for a meniscus repair.
if applicable

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fraser Orthopaedic Research Society

Investigators

  • Principal Investigator: Robert G. McCormack, MD, FRCSC, Simon Fraser Orthopaedic Fund / Fraser Health Authority / University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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