Clinical trial NCT01991353: Platelet Rich Plasma Study With Meniscal Repair
Official title: Prospective, Double Blind, Randomized Trial: Meniscal Repair With or Without Augmentation Utilizing Platelet Rich Plasma.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Meniscus Lesion
Keywords: Knee
meniscus
platelet rich plasma
Lead sponsor: Fraser Orthopaedic Research Society
Sponsor class: NETWORK
First posted: 2013-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: MRA (magnetic resonance imaging arthrography
timeFrame: 6 months
Secondary outcomes:
measure: WOMET - Western Ontario Meniscal Outcome Measure
timeFrame: Baseline, 3 months, 6 months 12 months
measure: VAS Pain Score - Visual Analog Scale
timeFrame: Baseline, Post-op Day 1, 6 weeks
measure: Range of motion
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Tegner Score
timeFrame: Baseline, 3, 6 and 12 months post treatment
Other outcomes:
measure: Second look arthroscopy
timeFrame: if applicable
Locations:
city: Port Moody
country: Canada
facility: Eagle Ridge Hospital
state: British Columbia
Study officials:
affiliation: Simon Fraser Orthopaedic Fund / Fraser Health Authority / University of British Columbia
name: Robert G. McCormack, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
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