Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip

Study Overview
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Brief Summary
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The current management of osteoarthritis is based on non-pharmacological and pharmacological means which include intra-articular injections. The recommendations on the management of hip osteoarthritis stipulate that intra-articular injections of corticosteroid may be considered in patients with an exacerbation not responding to oral treatments. Several recent studies show the effectiveness of intra-articular corticosteroids compared with anesthetics. The intra-articular injection of viscosupplementation alone has never been validated in this indication since controlled studies did not show efficacy over placebo. At present, viscosupplementation is considered an anti-osteoarthritic symptomatic slow-acting and its interest is not yet established in hip osteoarthritis.

Detailed Description
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Show the superiority of intra-articular injection of viscosupplementation in combination with corticosteroid compared to intra-articular injection of corticosteroid alone in the treatment of hip osteoarthritis.

Official Title
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Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Device: Experimental group
* Device: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with hip osteoarthrosis (stage II et III according Kellgren et Lawrence) walking alone patients patient consenting to participate to the study patient enrolled in the national healthcare insurance program patient older than 18 years Exclusion Criteria: Patients with hip osteoarthrosis (stage I et IV according Kellgren et Lawrence) patients with rapidly destructive hip osteoarthritis patients with inflammatory rheumatism patients with microcrystalline arthritis patients with hip osteonecrosis patients who received corticosteroids during the previous three months patients who received a intra articular injection of viscosupplementation during the previous six months patient with haemostatic disorder patient with consumption of painkillers tier 3

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: injection of viscosupplementation and corticosteroid<br>experimental group | Device: Experimental group<br>* patient receive intra articular injection (hip joint) of viscosupplementation in combination with corticosteroid<br>|
| Active Comparator: injection of corticosteroid<br>control group | Device: control group<br>* patient receive intra articular injection (hip joint) of corticosteroid alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improving pain | decrease of 20 mm on a visual analog pain scale between the evaluation at day 0 and the evaluation at 3 months | 3 months |