Gait Analysis Following Knee Viscosupplementation

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

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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