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

Phase 4

Completed

• Conditions: Hip Osteoarthritis
• Interventions: Drug: Bupivacaine; Drug: Hyaluronan

• Registration Number: NCT02086474
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Study Start: 2014-05
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine	one Marcain extra-capsular injection
Hyaluronan	Hyaluronan	Hyaluronan acid Neovisc : one 6cc (viscosupplement) intra-articular injection

Primary Outcome Measures

Name	Time	Method
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
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

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

Trial Locations

Locations (1)

Pavillon de l'Éducation Physique et des Sports - Université Laval; 🇨🇦 Quebec, Canada