Gait Analysis Following Knee Viscosupplementation

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636971
• Other study ID #: CER-VD No 273/13
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 2013
• Est. completion date: January 1, 2017

Study information

• Verified date: August 2018
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 1, 2017
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gait
• Injection
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• hyaluronic acid with mannitol
single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)
• hyaluronic acid with sorbitol
single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)
• Placebos
single shot injection of saline, same volume

Locations

Country	Name	City	State
Switzerland	CHUV - Hopital Orthopedique	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Brigitte Jolles, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	UCLA- activity scale	Activity numerical ordinal scale ranging from 1 (lowest) to 10 (highest)	4 weeks following injection
Secondary	Visual Analogue Scale (VAS) pain	continual numerical scale (0-10), 0 the best score (no pain) and 10 the worst.	4 weeks following injection