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

Phase 3

Completed

• Conditions: Hip Osteoarthritis
• Interventions: Device: Experimental group; Device: control group

• Registration Number: NCT02862639
• Lead Sponsor: CHU de Reims

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-11
• Status Verified: 2016-09
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
injection of viscosupplementation and corticosteroid	Experimental group	experimental group
injection of corticosteroid	control group	control group

Primary Outcome Measures

Name	Time	Method
improving pain	3 months	decrease of 20 mm on a visual analog pain scale between the evaluation at day 0 and the evaluation at 3 months

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France