Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA
Completed · Not applicable
Conditions studied: Osteoarthritis
In brief
The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee OA.
Key facts
- Study ID
- NCT02110238
- Run by
- Bioventus LLC
- People needed
- 421
- Starts
- 2014-03-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2021-03-09
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical evidence of symptomatic osteoarthritis of the study knee as classified according to Altman criteria.
- Symptoms in study knee for at least one year prior to the screening visit
- Verified OA of the study knee of Grade 2 or 3 according to a modification of the grading system of Kellgren-Lawrence (K-L) radiographic severity.
- Willingness to discontinue NSAIDs (systemic and topical) and non-acetaminophen analgesic use seven days or five half-lives prior to the first injection and throughout the study.
You may not qualify if…
- Inability to perform a 50 foot walk test.
- Subjects with rheumatoid arthritis, joint infection, other inflammatory and metabolic arthritis, Lupus or dermatologic disorder or skin conditions in close proximity to study knee that would preclude safe intra-articular injections.
- Prior hyaluronic acid injections into the study knee within six months of the screening visit.
- Intra-articular or intra-muscular steroid injections within three months of the screening visit or during study participation. Oral corticosteroids within four weeks of the screening visit or during study participation.
- History of surgical treatment to the study knee or arthroscopic intervention within three months prior to the screening visit.
- Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
- Subjects with clinically diagnosed symptomatic OA of the hip.
Where it is running
- Triangle Orthopaedic Associates — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.