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

NCT ID: NCT02862639

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-11-30

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.

Conditions

Hip Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

injection of viscosupplementation and corticosteroid

experimental group

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: DEVICE

patient receive intra articular injection (hip joint) of viscosupplementation in combination with corticosteroid

injection of corticosteroid

control group

Group Type: ACTIVE_COMPARATOR

control group

Intervention Type: DEVICE

patient receive intra articular injection (hip joint) of corticosteroid alone

Interventions

Experimental group

patient receive intra articular injection (hip joint) of viscosupplementation in combination with corticosteroid

Intervention Type: DEVICE

control group

patient receive intra articular injection (hip joint) of corticosteroid alone

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu de Reims

Reims, , France

Countries

France

Other Identifiers

PA12069

Identifier Type: -

Identifier Source: org_study_id