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WITHDRAWN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
2015-07-31
Study Completion Date
2018-01-31
Brief Summary
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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.
Null Hypothesis: There is no difference in meniscal healing with or without the use of PRP.
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Detailed Description
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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.
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.
Conditions
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Meniscus Lesion
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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With PRP
Standardized meniscal repair with PRP (platelet rich plasma) in the meniscal healing bed.
Group Type
EXPERIMENTAL
With PRP
Intervention Type
PROCEDURE
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.
Without PRP
Standardized meniscal repair without PRP (platelet rich plasma).
Group Type
ACTIVE_COMPARATOR
Without PRP
Intervention Type
PROCEDURE
Standard of care meniscal repair without augmentation.
Interventions
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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.
Intervention Type
PROCEDURE
Without PRP
Standard of care meniscal repair without augmentation.
Intervention Type
PROCEDURE
Other Intervention Names
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Platelet Rich Fibrin Matrix (PRFM)
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fraser Orthopaedic Research Society
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Robert G. McCormack, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Simon Fraser Orthopaedic Fund / Fraser Health Authority / University of British Columbia
Locations
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Eagle Ridge Hospital
Port Moody, British Columbia, Canada
Site Status
Countries
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Canada
References
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RESULT
Other Identifiers
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2013-122
Identifier Type: -
Identifier Source: org_study_id
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