Post-op Treatment With Hyaluronic Acid Injections

The Hawkins Foundation

Status: Terminated

Conditions: Meniscus Tear; Chondropathy/Degenerative Joint Disease (DJD)

Treatments: Other: Saline; Device: Euflexxa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01256788

Pro00007133

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

34 participants in 2 patient groups, including a placebo group

Viscosupplementation

Experimental group

Description:

Hyaluronic acid injection

Treatment:

Device: Euflexxa

Saline injection

Placebo Comparator group

Treatment:

Other: Saline