Post-op Treatment With Hyaluronic Acid Injections

Meniscus Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01256788
• Other study ID #: Pro00007133
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cartilage Diseases
• Chondropathy/Degenerative Joint Disease (DJD)
• Joint Diseases
• Meniscus Tear
• Osteoarthritis

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