Gait Analysis Following Knee Viscosupplementation

Sponsor

Brigitte Jolles, MD (Other)

Overall Status

Completed

CT.gov ID

NCT03636971

Collaborator

(none)

Enrollment

Location

Arms

44.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gait Knee Osteoarthritis Injection	Drug: hyaluronic acid with mannitol Drug: hyaluronic acid with sorbitol Drug: Placebos	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Screening

Official Title:

Gait Analysis Following Single-shot Hyaluronic Acid Supplementation: a Pilot Randomised Double-blinded Clinical Trial

Actual Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Dec 30, 2015

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hyaluronic acid with mannitol	Drug: hyaluronic acid with mannitol single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)
Experimental: hyaluronic acid with sorbitol	Drug: hyaluronic acid with sorbitol single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)
Active Comparator: saline	Drug: Placebos single shot injection of saline, same volume

Arm

Intervention/Treatment

Experimental: hyaluronic acid with mannitol

Drug: hyaluronic acid with mannitol

single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)

Experimental: hyaluronic acid with sorbitol

Drug: hyaluronic acid with sorbitol

single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)

Active Comparator: saline

Drug: Placebos

single shot injection of saline, same volume

Outcome Measures

Primary Outcome Measures

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

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.
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.
UCLA- activity scale [4 weeks following injection]
Activity numerical ordinal scale ranging from 1 (lowest) to 10 (highest)
Visual Analogue Scale (VAS) pain [4 weeks following injection]
continual numerical scale (0-10), 0 the best score (no pain) and 10 the worst.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHUV - Hopital Orthopedique	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

Brigitte Jolles, MD

Investigators

Study Chair: Brigitte Brigitte, CHUV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brigitte Jolles, MD, Professor, University of Lausanne Hospitals

ClinicalTrials.gov Identifier:

NCT03636971

Other Study ID Numbers:

CER-VD No 273/13

First Posted:

Aug 17, 2018

Last Update Posted:

Aug 17, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2018