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Post-op Treatment With Hyaluronic Acid Injections

NCT01256788 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-01-08

Study results available
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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.

Conditions

  • Meniscus Tear
  • Chondropathy/Degenerative Joint Disease (DJD)

Interventions

DEVICE

Euflexxa

4 injections of 2ml of Euflexxa

OTHER

Saline

4 injections of 3 ml of sterile saline

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • The Hawkins Foundation

    lead OTHER

Principal Investigators

  • Thomas Pace, MD · Greenville Hospital System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01256788 on ClinicalTrials.gov