N/A
Completed N=814
Gel-One Treatment in Knee Osteoarthritis
Osteoarthritis Knee
Source: ClinicalTrials.gov NCT01934218 ↗
Enrolled (actual)
814
Serious AEs
1.6%
Results posted
Jul 2017
Primary outcomePrimary: Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26 — -31.7; -31.7 mm — p=0.988
Summary
The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26 |
-31.7; -31.7 | 0.988 |
Eligibility Criteria
Inclusion Criteria
- Have a knee pain
- Grade 1 to 3 on the Kellgren-Lawrence grading scale
Exclusion Criteria
- BMI greater than 35 kg/m2
- Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening
- Had a joint replacement of the target knee
Data sourced from ClinicalTrials.gov (NCT01934218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.