Post-op Treatment With Hyaluronic Acid Injections

NCT01256788 | Terminated Results DMC

• 1 other identifier: Pro00007133
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniscus Tear; Chondropathy/Degenerative Joint Disease (DJD)

Keywords

viscosupplementation; meniscus tear; degenerative joint disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Viscosupplementation

EXPERIMENTAL

Hyaluronic acid injection

Device: Euflexxa

Saline injection

PLACEBO COMPARATOR

Other: Saline

Interventions

Euflexxa DEVICE

4 injections of 2ml of Euflexxa

Viscosupplementation

Saline OTHER

4 injections of 3 ml of sterile saline

Saline injection

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hawkins Foundation: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Cartilage Diseases; Joint Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Early termination due to new insurance coverage for post-operative knee viscosupplementation leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Douglas Wyland
• Organization: Steadman Hawkins Clinic of the Carolinas/Greenville Health System

dwyland@ghs.org

864-454-7422

Study Officials

• Thomas Pace, MD

  Greenville Hospital System

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The two treatment groups were: 1. Received saline injection 2. Received viscosupplementation injection

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 9, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 8, 2019
• Results First Posted: January 8, 2019

Record last verified: 2018-12

Locations

US (1)