Post-op Treatment With Hyaluronic Acid Injections

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-04-30

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.

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Detailed Description

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Conditions

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Meniscus Tear Chondropathy/Degenerative Joint Disease (DJD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The two treatment groups were:

1. Received saline injection
2. Received viscosupplementation injection

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Viscosupplementation

Hyaluronic acid injection

Group Type EXPERIMENTAL

Euflexxa

Intervention Type DEVICE

4 injections of 2ml of Euflexxa

Saline injection

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

4 injections of 3 ml of sterile saline

Interventions

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Euflexxa

4 injections of 2ml of Euflexxa

Intervention Type DEVICE

Saline

4 injections of 3 ml of sterile saline

Intervention Type OTHER

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No