Post-op Treatment With Hyaluronic Acid Injections

Study Overview
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Brief Summary
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This study will look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are randomized into the injection group will receive a series of three injections (one a week for 3 weeks), then a booster injection at 6 months post-op. Several questionnaires will be given after the first set of injections, then again at a one year follow-up. The hypothesis is that patients receiving hyaluronic acid injections will have better pain and function scores as compared with placebo and no further treatment at all time points.

Official Title
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Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears

Conditions
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Meniscus Tear, Chondropathy/Degenerative Joint Disease (DJD)

Intervention / Treatment
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* Device: Euflexxa
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in post-op stage of treatment for meniscal tears or chondropathy/DJD Over 40 years of age A daily knee pain above 20mm on a 100mm visual analogue scale Exclusion Criteria: Previous recipient of viscosupplementation injections Had rheumatoid arthritis or other inflammatory arthritis Had intra-articular steroid injections within the previous 2 months Invasive knee procedures within the past 6 months Contraindications to hyaluronate (an allergy) Medications that could interfere with the planned interventions

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The two treatment groups were: Received saline injection Received viscosupplementation injection
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viscosupplementation<br>Hyaluronic acid injection | Device: Euflexxa<br>* 4 injections of 2ml of Euflexxa<br>|
| Placebo Comparator: Saline injection<br> | Other: Saline<br>* 4 injections of 3 ml of sterile saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tegner Activity Level Scale Score | The Tegner Scoring system is a numeric scale range from 1 to 10, with each value indicating the ability to perform a specific activity. The scoring system is ordinal in nature and reflects lower to higher levels of activity participation, with higher numbers indicating a higher level of function. | 1 yr postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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viscosupplementation, meniscus tear, degenerative joint disease