Platelet Rich Plasma Study With Meniscal Repair

Not Applicable

Withdrawn

• Conditions: Meniscus Lesion
• Interventions: Procedure: Without PRP; Procedure: With PRP

• Registration Number: NCT01991353
• Lead Sponsor: Fraser Orthopaedic Research Society

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Study Start: 2015-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19
• Primary Completion: 2017-07
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without PRP	Without PRP	Standardized meniscal repair without PRP (platelet rich plasma).
With PRP	With PRP	Standardized meniscal repair with PRP (platelet rich plasma) in the meniscal healing bed.

Primary Outcome Measures

Name	Time	Method
MRA (magnetic resonance imaging arthrography	6 months	The primary outcome measures will be assessment of meniscal healing integrity using magnetic resonance imaging arthrography six months post repair.

Secondary Outcome Measures

Name	Time	Method
WOMET - Western Ontario Meniscal Outcome Measure	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.
VAS Pain Score - Visual Analog Scale	Baseline, Post-op Day 1, 6 weeks	Pain Visual Analog Scale.
Range of motion	6 weeks, 3 months, 6 months, 12 months	Knee range of motion measurements.
Tegner Score	Baseline, 3, 6 and 12 months post treatment	Return to pre injury activity level as measured by the Tegner Score.

Trial Locations

Locations (1)

Eagle Ridge Hospital; 🇨🇦 Port Moody, British Columbia, Canada