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

Study 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.

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

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Hyaluronan
* Drug: Bupivacaine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronan<br>Hyaluronan acid Neovisc : one 6cc (viscosupplement) intra-articular injection | Drug: Hyaluronan<br>* Intra-articular injection<br>* Other names: Hyaluronan acid : Neovisc®;|
| Placebo Comparator: Bupivacaine<br>one Marcain extra-capsular injection | Drug: Bupivacaine<br>* Extra-capsular injection<br>* 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 | Subtraction between maximum and minimum flexion measured with motion capture system during gait | Change from Baseline at 6 months | 
| Change in daily physical activity | 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 | Questionnaires HOOS | change from Baseline at 6 months | 
| Change in quality of life | Questionnaires: MOS-SF36 and HOOS | Change from Baseline at 6 months | 
| Change in walking cadence | Measured during 3D gait analysis | Change from Baseline at 6 months |