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

C

CHU de Reims

Status and phase

Completed
Phase 3

Conditions

Hip Osteoarthritis

Treatments

Device: control group
Device: Experimental group

Study type

Interventional

Funder types

Other

Identifiers

NCT02862639
PA12069

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

43 participants in 2 patient groups

injection of viscosupplementation and corticosteroid
Experimental group
Description:
experimental group
Treatment:
Device: Experimental group
injection of corticosteroid
Active Comparator group
Description:
control group
Treatment:
Device: control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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