Gait Analysis Following Knee Viscosupplementation

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Osteoarthritis, Injection, Gait

Intervention / Treatment
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* Drug: hyaluronic acid with mannitol
* Drug: hyaluronic acid with sorbitol
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Speed | 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...) | 4 weeks following injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KSS specific knee mobility scale | 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. | 4 weeks following injection | 
| EuroQool -5 dimensions self-reported scale of quality of life | 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. | 4 weeks following injection | 
| UCLA- activity scale | Activity numerical ordinal scale ranging from 1 (lowest) to 10 (highest) | 4 weeks following injection | 
| Visual Analogue Scale (VAS) pain | continual numerical scale (0-10), 0 the best score (no pain) and 10 the worst. | 4 weeks following injection |