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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02862639
Acronym
VISCOSUPP-HIP
Enrollment
43
Registered
2016-08-11
Start date
2014-02-28
Completion date
2015-11-30
Last updated
2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis

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.

Interventions

DEVICEExperimental group

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

DEVICEcontrol group

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

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
improving pain3 monthsdecrease of 20 mm on a visual analog pain scale between the evaluation at day 0 and the evaluation at 3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026