Meniscus Tear Clinical Trial
Official title:
Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears
NCT number | NCT01256788 |
Other study ID # | Pro00007133 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2010 |
Est. completion date | April 2014 |
Verified date | December 2018 |
Source | The Hawkins Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 34 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Steadman Hawkins Clinic of the Carolinas | Greenville | South Carolina |
Lead Sponsor | Collaborator |
---|---|
The Hawkins Foundation | Ferring Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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