Gait Analysis Following Knee Viscosupplementation

B

Brigitte Jolles, MD

Status and phase

Completed
Phase 3
Phase 2

Conditions

Injection
Gait
Knee Osteoarthritis

Treatments

Drug: Placebos
Drug: hyaluronic acid with sorbitol
Drug: hyaluronic acid with mannitol

Study type

Interventional

Funder types

Other

Identifiers

NCT03636971
CER-VD No 273/13

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

diagnosis of primary knee OA Ahlbäck II-III and signed consent forms.

Exclusion criteria

recent history of infection, diabetes, neurological impairment, chronic venous or lymphatic stasis, pain medication of level 2 or 3, psychiatric conditions, contraindications for HA joint injection and previous HA or steroid injections in the last six months.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

22 participants in 3 patient groups

hyaluronic acid with mannitol
Experimental group
Treatment:
Drug: hyaluronic acid with mannitol
hyaluronic acid with sorbitol
Experimental group
Treatment:
Drug: hyaluronic acid with sorbitol
saline
Active Comparator group
Treatment:
Drug: Placebos

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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