Daily Activity and Gait Analysis After Viscosupplement Injection Among Hip Osteoarthritis Patients

August 9, 2018 updated by: Philippe Corbeil, Laval University

Daily Activity Quantification and Gait Pattern Analysis Before and After Intra-articular Injection of Viscosupplement Among Hip Osteoarthritis Patients

The objective of this study is to assess the changes in daily physical activity and gait pattern, following a viscosupplement injection among a population who is suffering from hip osteoarthritis. A kinetic and kinematic gait analysis, an Actigraph activity monitor, a functional Timed-Stair-Test and two questionnaires (Medical Outcome Study Short-Form36 (MOS-SF36), Hip disability and Osteoarthritis Outcome Score (HOOS)) about how the pathology affects the quality of life, will be use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 0A6
        • Pavillon de l'Éducation Physique et des Sports - Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • From 45 years old to 65 years old
  • Clinically symptomatic moderate or severe hip osteoarthritis (Tönnis Grade II to III)
  • Capacity to keep steady upright position and walking during 15 minutes
  • Body mass index < 40kg/m2

Exclusion Criteria:

  • Bilateral hip osteoarthritis
  • No broken hip or leg during the last 12 months
  • Bone necrosis
  • Rheumatoid arthritis, articular chondrocalcinosis, metabolic bone disease, psoriasis, gout, active infection
  • Per os corticosteroid treatment
  • Corticosteroid injection < 3 months
  • Viscosupplement injection < 6 months
  • Hypersensitivity to hyaluronic acid products
  • Planed surgery during study duration
  • Physical or mental disability to fill in questionnaires and/or to participate to follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronan
Hyaluronan acid Neovisc : one 6cc (viscosupplement) intra-articular injection
Drug: Hyaluronan
Intra-articular injection
Other Names:
  • Hyaluronan acid : Neovisc®
Placebo Comparator: Bupivacaine
one Marcain extra-capsular injection
Drug: Bupivacaine
Extra-capsular injection
Other Names:
  • Bupivacaine: Marcaine®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hip flexion-extension range of motion
Time Frame: Change from Baseline at 6 months
Subtraction between maximum and minimum flexion measured with motion capture system during gait
Change from Baseline at 6 months
Change in daily physical activity
Time Frame: Change from Baseline at 6 months
Intensity and duration of the daily physical activity measured with pedometer
Change from Baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hip pain
Time Frame: change from Baseline at 6 months
Questionnaires HOOS
change from Baseline at 6 months
Change in quality of life
Time Frame: Change from Baseline at 6 months
Questionnaires: MOS-SF36 and HOOS
Change from Baseline at 6 months
Change in walking cadence
Time Frame: Change from Baseline at 6 months
Measured during 3D gait analysis
Change from Baseline at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Antoine Cantin-Warren, B.Sc., Laval University
  • Study Director: Étienne L. Belzile, MD, Laval University
  • Study Director: Philippe Corbeil, Ph.D., Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INF-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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