Back to resultsGait Analysis Following Knee Viscosupplementation
Primary Purpose
Gait, Knee Osteoarthritis, Injection
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
hyaluronic acid with mannitol
hyaluronic acid with sorbitol
Placebos
Sponsored by
About this trial
This is an interventional screening trial for Gait
Eligibility 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.
Sites / Locations
- CHUV - Hopital Orthopedique
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
hyaluronic acid with mannitol
hyaluronic acid with sorbitol
saline
Arm Description
Outcomes
Primary Outcome Measures
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...)
Secondary Outcome Measures
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.
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.
UCLA- activity scale
Activity numerical ordinal scale ranging from 1 (lowest) to 10 (highest)
Visual Analogue Scale (VAS) pain
continual numerical scale (0-10), 0 the best score (no pain) and 10 the worst.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03636971
Brief Title
Gait Analysis Following Knee Viscosupplementation
Official Title
Gait Analysis Following Single-shot Hyaluronic Acid Supplementation: a Pilot Randomised Double-blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
December 30, 2015 (Actual)
Study Completion Date
January 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brigitte Jolles, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Knee Osteoarthritis, Injection
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hyaluronic acid with mannitol
Arm Type
Experimental
Arm Title
hyaluronic acid with sorbitol
Arm Type
Experimental
Arm Title
saline
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid with mannitol
Intervention Description
single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid with sorbitol
Intervention Description
single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
single shot injection of saline, same volume
Primary Outcome Measure Information:
Title
Gait Speed
Description
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
Secondary Outcome Measure Information:
Title
KSS specific knee mobility scale
Description
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
Title
EuroQool -5 dimensions self-reported scale of quality of life
Description
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
Title
UCLA- activity scale
Description
Activity numerical ordinal scale ranging from 1 (lowest) to 10 (highest)
Time Frame
4 weeks following injection
Title
Visual Analogue Scale (VAS) pain
Description
continual numerical scale (0-10), 0 the best score (no pain) and 10 the worst.
Time Frame
4 weeks following injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Brigitte
Organizational Affiliation
CHUV
Official's Role
Study Chair
Facility Information:
Facility Name
CHUV - Hopital Orthopedique
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31024734
Citation
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.
Results Reference
derived
Learn more about this trial
Gait Analysis Following Knee Viscosupplementation
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