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Gait Analysis Following Knee Viscosupplementation

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ClinicalTrials.gov Identifier: NCT03636971
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Brigitte Jolles, MD, University of Lausanne Hospitals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gait Knee Osteoarthritis Injection Drug: hyaluronic acid with mannitol Drug: hyaluronic acid with sorbitol Drug: Placebos Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Official Title: Gait Analysis Following Single-shot Hyaluronic Acid Supplementation: a Pilot Randomised Double-blinded Clinical Trial
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : December 30, 2015
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: hyaluronic acid with mannitol Drug: hyaluronic acid with mannitol
single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)
Experimental: hyaluronic acid with sorbitol Drug: hyaluronic acid with sorbitol
single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)
Active Comparator: saline Drug: Placebos
single shot injection of saline, same volume


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636971


Locations
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Switzerland
CHUV - Hopital Orthopedique
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Brigitte Jolles, MD
Investigators
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Study Chair: Brigitte Brigitte CHUV
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Brigitte Jolles, MD, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT03636971    
Other Study ID Numbers: CER-VD No 273/13
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Mannitol
Sorbitol
Hyaluronic Acid
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Cathartics
Gastrointestinal Agents