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Completed

NCT Number: NCT03636971

Gait Analysis Following Knee Viscosupplementation

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.

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Key information

Conditions

Gait Arthritis Injection Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHUV - Hopital Orthopedique

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hyaluronic acid with mannitol

Drug

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

hyaluronic acid with sorbitol

Drug

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

Placebos

Drug

single shot injection of saline, same volume

Primary outcomes

  1. Gait Speed

    Time frame: 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 outcomes

  1. KSS specific knee mobility scale

    Time frame: 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.

  2. EuroQool -5 dimensions self-reported scale of quality of life

    Time frame: 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.

  3. UCLA- activity scale

    Time frame: 4 weeks following injection

    Activity numerical ordinal scale ranging from 1 (lowest) to 10 (highest)

  4. Visual Analogue Scale (VAS) pain

    Time frame: 4 weeks following injection

    continual numerical scale (0-10), 0 the best score (no pain) and 10 the worst.

Sponsors and collaborators

Lead sponsor

Brigitte Jolles, MD

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Aug 17, 2018
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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