Gait Analysis Following Knee Viscosupplementation
NCT03636971 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2018-08-17
Summary
This is a pilot, double-blind, randomised trial that investigates which gait parameters are more sensitive following a single bolus injection of hyaluronic acid with mannitol, hyaluronic acid with sorbitol, or saline placebo for knee osteoarthritis. Outcome measures are gait analysis through a inertial sensors (Physilog), Knee Society Score (KSS), University of California Los Angeles (UCLA) activity-scale and EuroQol 5Dimensions. Follow-up will be of 4 weeks.
Conditions
- Gait
- Knee Osteoarthritis
- Injection
Interventions
- DRUG
-
hyaluronic acid with mannitol
single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)
- DRUG
-
hyaluronic acid with sorbitol
single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)
- DRUG
-
Placebos
single shot injection of saline, same volume
Sponsors & Collaborators
-
Brigitte Jolles, MD
lead OTHER
Principal Investigators
-
Brigitte Brigitte · CHUV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-01
- Primary Completion
- 2015-12-30
- Completion
- 2017-01-01
Countries
- Switzerland
Study Locations
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