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Completed

NCT Number: NCT02086474

Daily Activity and Gait Analysis After Viscosupplement Injection 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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pavillon de l'Éducation Physique et des Sports - Université Laval

Québec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronan

Drug

Intra-articular injection

Other names: Hyaluronan acid : Neovisc®

Bupivacaine

Drug

Extra-capsular injection

Other names: Bupivacaine: Marcaine®

Primary outcomes

  1. 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

  2. Change in daily physical activity

    Time frame: Change from Baseline at 6 months

    Intensity and duration of the daily physical activity measured with pedometer

Secondary outcomes

  1. Change in hip pain

    Time frame: change from Baseline at 6 months

    Questionnaires HOOS

  2. Change in quality of life

    Time frame: Change from Baseline at 6 months

    Questionnaires: MOS-SF36 and HOOS

  3. Change in walking cadence

    Time frame: Change from Baseline at 6 months

    Measured during 3D gait analysis

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2014
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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