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

Hip Osteoarthritis Clinical Trial

— VISCOSUPP-HIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862639
• Other study ID #: PA12069
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2016
• Last updated: July 26, 2017
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Experimental group
patient receive intra articular injection (hip joint) of viscosupplementation in combination with corticosteroid
• control group
patient receive intra articular injection (hip joint) of corticosteroid alone

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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