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

NCT02862639 | Completed Phase 3

• 1 other identifier: PA12069
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

injection of viscosupplementation and corticosteroid

EXPERIMENTAL

experimental group

Device: Experimental group

injection of corticosteroid

ACTIVE COMPARATOR

control group

Device: control group

Interventions

Experimental group DEVICE

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

injection of viscosupplementation and corticosteroid

control group DEVICE

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

injection of corticosteroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: February 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 27, 2017

Record last verified: 2016-09

Locations

FR (1)