Post-op Treatment With Hyaluronic Acid Injections

Not Applicable

Terminated

• Conditions: Chondropathy/Degenerative Joint Disease (DJD); Meniscus Tear
• Interventions: Other: Saline; Device: Euflexxa

• Registration Number: NCT01256788
• Lead Sponsor: The Hawkins Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2016-03-07
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Results First Posted: 2019-01-08
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline injection	Saline	-
Viscosupplementation	Euflexxa	Hyaluronic acid injection

Primary Outcome Measures

Name	Time	Method
Tegner Activity Level Scale Score	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.

Trial Locations

Locations (1)

Steadman Hawkins Clinic of the Carolinas; 🇺🇸 Greenville, South Carolina, United States