Meniscus Lesion Clinical Trial
Official title:
Prospective, Double Blind, Randomized Trial: Meniscal Repair With or Without Augmentation Utilizing Platelet Rich Plasma.
Verified date | April 2016 |
Source | Simon Fraser Orthopaedic Fund |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2018 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Eagle Ridge Hospital | Port Moody | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Simon Fraser Orthopaedic Fund |
Canada,
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* Note: There are 55 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Second look arthroscopy | 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 | No |
Primary | MRA (magnetic resonance imaging arthrography | The primary outcome measures will be assessment of meniscal healing integrity using magnetic resonance imaging arthrography six months post repair. | 6 months | No |
Secondary | WOMET - Western Ontario Meniscal Outcome Measure | 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 | No |
Secondary | VAS Pain Score - Visual Analog Scale | Pain Visual Analog Scale. | Baseline, Post-op Day 1, 6 weeks | No |
Secondary | Range of motion | Knee range of motion measurements. | 6 weeks, 3 months, 6 months, 12 months | No |
Secondary | Tegner Score | Return to pre injury activity level as measured by the Tegner Score. | Baseline, 3, 6 and 12 months post treatment | No |
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