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Clinical Trials/NCT02086474
NCT02086474
Completed
Phase 4

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

Laval University1 site in 1 country38 target enrollmentMay 2014

Overview

Phase
Phase 4
Intervention
Hyaluronan
Conditions
Hip Osteoarthritis
Sponsor
Laval University
Enrollment
38
Locations
1
Primary Endpoint
Change in hip flexion-extension range of motion
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
August 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Philippe Corbeil

PhD

Laval University

Eligibility Criteria

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

Arms & Interventions

Hyaluronan

Hyaluronan acid Neovisc : one 6cc (viscosupplement) intra-articular injection

Intervention: Hyaluronan

Bupivacaine

one Marcain extra-capsular injection

Intervention: Bupivacaine

Outcomes

Primary Outcomes

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 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

  • Change in hip pain(change from Baseline at 6 months)
  • Change in quality of life(Change from Baseline at 6 months)
  • Change in walking cadence(Change from Baseline at 6 months)

Study Sites (1)

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