Gait Analysis Following Knee Viscosupplementation

Gait Analysis Following Single-shot Hyaluronic Acid Supplementation: a Pilot Randomised Double-blinded Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Gait; Injection
• Intervention / Treatment: Drug: hyaluronic acid with mannitol; Drug: hyaluronic acid with sorbitol; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • CHUV - Hopital Orthopedique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Brigitte Jolles, MD
• Investigators: Study Chair: Brigitte Brigitte, CHUV

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): December 30, 2015
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Gastrointestinal Agents; Protective Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Adjuvants, Immunologic; Cathartics; Viscosupplements; Mannitol; Sorbitol; Hyaluronic Acid
• Other Study ID Numbers: CER-VD No 273/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No