Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Meniscus Tear
- Sponsor
- The Hawkins Foundation
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Tegner Activity Level Scale Score
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Tegner Activity Level Scale Score
Time Frame: 1 yr postop
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.