Post-op Treatment With Hyaluronic Acid Injections

December 18, 2018 updated by: The Hawkins Foundation

Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Steadman Hawkins Clinic of the Carolinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline injection
Other: Saline
4 injections of 3 ml of sterile saline
Experimental: Viscosupplementation
Hyaluronic acid injection
Device: Euflexxa
4 injections of 2ml of Euflexxa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tegner Activity Level Scale Score
Time Frame: 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.
1 yr postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hawkins Foundation

Collaborators

Ferring Pharmaceuticals

Investigators

  • Study Chair: Thomas Pace, MD, Greenville Hospital System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 7, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00007133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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