NCT03636971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2.7 years

First QC Date

August 6, 2018

Last Update Submit

August 16, 2018

Conditions

GaitKnee OsteoarthritisInjection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • KSS specific knee mobility scale

    4 weeks following injection

  • EuroQool -5 dimensions self-reported scale of quality of life

    4 weeks following injection

  • UCLA- activity scale

    4 weeks following injection

  • Visual Analogue Scale (VAS) pain

    4 weeks following injection

Study Arms (3)

hyaluronic acid with mannitol

EXPERIMENTAL
Drug: hyaluronic acid with mannitol

hyaluronic acid with sorbitol

EXPERIMENTAL
Drug: hyaluronic acid with sorbitol

saline

ACTIVE COMPARATOR
Drug: Placebos

Interventions

hyaluronic acid with mannitolDRUG

single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)

hyaluronic acid with mannitol
hyaluronic acid with sorbitolDRUG

single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)

hyaluronic acid with sorbitol
PlacebosDRUG

single shot injection of saline, same volume

saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of primary knee OA Ahlbäck II-III and signed consent forms.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV - Hopital Orthopedique

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 31024734DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic AcidMannitolSorbitol

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesSugar AlcoholsAlcoholsOrganic Chemicals

Study Officials

  • Brigitte Brigitte

    CHUV

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 17, 2018

Study Start

May 1, 2013

Primary Completion

December 30, 2015

Study Completion

January 1, 2017

Last Updated

August 17, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)