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Post-op Treatment With Hyaluronic Acid Injections

Primary Purpose

Meniscus Tear, Chondropathy/Degenerative Joint Disease (DJD)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Euflexxa
Saline
Sponsored by
The Hawkins Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniscus Tear focused on measuring viscosupplementation, meniscus tear, degenerative joint disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Steadman Hawkins Clinic of the Carolinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Viscosupplementation

Saline injection

Arm Description

Hyaluronic acid injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2010
Last Updated
December 18, 2018
Sponsor
The Hawkins Foundation
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01256788
Brief Title
Post-op Treatment With Hyaluronic Acid Injections
Official Title
Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Insurance now covers post-op HA injections, drastically decreasing enrollment.
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hawkins Foundation
Collaborators
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Tear, Chondropathy/Degenerative Joint Disease (DJD)
Keywords
viscosupplementation, meniscus tear, degenerative joint disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The two treatment groups were: Received saline injection Received viscosupplementation injection
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Viscosupplementation
Arm Type
Experimental
Arm Description
Hyaluronic acid injection
Arm Title
Saline injection
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Euflexxa
Intervention Description
4 injections of 2ml of Euflexxa
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
4 injections of 3 ml of sterile saline
Primary Outcome Measure Information:
Title
Tegner Activity Level Scale Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Pace, MD
Organizational Affiliation
Greenville Hospital System
Official's Role
Study Chair
Facility Information:
Facility Name
Steadman Hawkins Clinic of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States

12. IPD Sharing Statement

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Post-op Treatment With Hyaluronic Acid Injections

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