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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01256788
Other study ID # Pro00007133
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date April 2014

Study information

Verified date December 2018
Source The Hawkins Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 34
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Euflexxa
4 injections of 2ml of Euflexxa
Other:
Saline
4 injections of 3 ml of sterile saline

Locations

Country Name City State
United States Steadman Hawkins Clinic of the Carolinas Greenville South Carolina

Sponsors (2)

Lead Sponsor Collaborator
The Hawkins Foundation Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 yr postop
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