Gait Analysis Following Knee Viscosupplementation

Phase 2

Completed

• Conditions: Knee Osteoarthritis; Injection; Gait
• Interventions: Drug: Placebos; Drug: hyaluronic acid with mannitol; Drug: hyaluronic acid with sorbitol

• Registration Number: NCT03636971
• Lead Sponsor: Brigitte Jolles, MD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2015-12-30
• Study Completion: 2017-01-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-16
• Last Update Submitted: 2018-08-16
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	Placebos	-
hyaluronic acid with mannitol	hyaluronic acid with mannitol	-
hyaluronic acid with sorbitol	hyaluronic acid with sorbitol	-

Primary Outcome Measures

Name	Time	Method
Gait Speed	4 weeks following injection	measured over the 30m of the test trial using an inertial-based system (Physilog, BioAGM, CH) following a previously validated protocol. Spatiotemporal parameters are analysed (i.e. gait speed, cadence, limping...)

Secondary Outcome Measures

Name	Time	Method
UCLA- activity scale	4 weeks following injection	Activity numerical ordinal scale ranging from 1 (lowest) to 10 (highest)
EuroQool -5 dimensions self-reported scale of quality of life	4 weeks following injection	The EQ-5D-5L essentially consists on the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).; The descriptive system comprises 5dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.Each dimension comprising the EQ-5D descriptive system is divided into 5levels of perceived problems:Level 1:no problem Level 2:slight problems Level 3: moderate problems Level 4:severe problems Level 5: extreme problems. A unique health state is defined by combining 1 level from each of the 5 dimensions.A total of 3125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code.; The EQ VAS records the patient's self-rated health on a 20cm vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
KSS specific knee mobility scale	4 weeks following injection	Knee specific clinician-based mobility scale based on clinical examination. Score interpretation: 80-100 Excellent, Score 70-79 Good, Score 60-69 Fair, score below 60 Poor.
Visual Analogue Scale (VAS) pain	4 weeks following injection	continual numerical scale (0-10), 0 the best score (no pain) and 10 the worst.

Trial Locations

Locations (1)

CHUV - Hopital Orthopedique; 🇨🇭 Lausanne, Vaud, Switzerland