Gait, Injection, Knee Osteoarthritis
Conditions
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.
Interventions
DRUGPlacebos
single shot injection of saline, same volume
DRUGhyaluronic acid with mannitol
single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)
DRUGhyaluronic acid with sorbitol
single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)
Sponsors
Brigitte Jolles, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Outcome results
None listed