A Phase 2/3 interventional study of hyaluronic acid with mannitol and hyaluronic acid with sorbitol in Gait, Knee Osteoarthritis and Injection, sponsored by Brigitte Jolles, MD. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by Brigitte Jolles, MD · Phase 2/3, Interventional, and Screening
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 22 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Brigitte Jolles, MD is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: hyaluronic acid with mannitol
Drug: hyaluronic acid with sorbitol
Drug: Placebos
single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)
single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)
single shot injection of saline, same volume
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...)
Time frame: 4 weeks following injection
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.
Time frame: 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.
Time frame: 4 weeks following injection
UCLA- activity scale
Activity numerical ordinal scale ranging from 1 (lowest) to 10 (highest)
Time frame: 4 weeks following injection
Visual Analogue Scale (VAS) pain
continual numerical scale (0-10), 0 the best score (no pain) and 10 the worst.
Time frame: 4 weeks following injection
Plan to share: No
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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