Post-op Treatment With Hyaluronic Acid Injections

The Hawkins Foundation34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Meniscus Tear Chondropathy/Degenerative Joint Disease (DJD)

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

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.

Time frame: 1 yr postop