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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyaluronic acid with mannitol | Experimental |
| |
| hyaluronic acid with sorbitol | Experimental |
| |
| saline | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyaluronic acid with mannitol | Drug | single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Brigitte | CHUV | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUV - Hopital Orthopedique | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31024734 | Derived | Pereira LC, Schweizer C, Moufarrij S, Krahenbuhl SM, Favre J, Gremion G, Applegate LA, Jolles BM. Gait analysis following single-shot hyaluronic acid supplementation: a pilot randomized double-blinded controlled trial. Pilot Feasibility Stud. 2019 Apr 22;5:56. doi: 10.1186/s40814-019-0443-4. eCollection 2019. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D008353 | Mannitol |
| D013012 | Sorbitol |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013402 | Sugar Alcohols |
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| hyaluronic acid with sorbitol | Drug | single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD) |
|
| Placebos | Drug | single shot injection of saline, same volume |
|
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 |
| D012216 |
| Rheumatic Diseases |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |