Gait Analysis Following Knee Viscosupplementation

NCT03636971 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-08-17

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636971 on ClinicalTrials.gov