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

Sponsor
Laval University (Other)
Overall Status
Completed
CT.gov ID
NCT02086474
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
39
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Daily Activity Quantification and Gait Pattern Analysis Before and After Intra-articular Injection of Viscosupplement Among Hip Osteoarthritis Patients
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in hip flexion-extension range of motion [Change from Baseline at 6 months]

      Subtraction between maximum and minimum flexion measured with motion capture system during gait

    2. Change in daily physical activity [Change from Baseline at 6 months]

      Intensity and duration of the daily physical activity measured with pedometer

    Secondary Outcome Measures

    1. Change in hip pain [change from Baseline at 6 months]

      Questionnaires HOOS

    2. Change in quality of life [Change from Baseline at 6 months]

      Questionnaires: MOS-SF36 and HOOS

    3. Change in walking cadence [Change from Baseline at 6 months]

      Measured during 3D gait analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pavillon de l'Éducation Physique et des Sports - Université Laval Quebec Canada G1V 0A6

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Philippe Corbeil, PhD, Laval University
    ClinicalTrials.gov Identifier:
    NCT02086474
    Other Study ID Numbers:
    • INF-2014
    First Posted:
    Mar 13, 2014
    Last Update Posted:
    Aug 10, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Hip
    Bupivacaine
    Hyaluronic Acid

    Study Results

    No Results Posted as of Aug 10, 2018