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

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu de Reims

Reims, 51092, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Group

Device

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

Control group

Device

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

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

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: VISCOSUPP-HIP

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Aug 11, 2016
Registry last updated: Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed