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Clinical Trials/NCT02862639
NCT02862639
Completed
Phase 3

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

CHU de Reims1 site in 1 country43 target enrollmentFebruary 2014

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
CHU de Reims
Enrollment
43
Locations
1
Primary Endpoint
improving pain
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
November 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

improving pain

Time Frame: 3 months

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

Study Sites (1)

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