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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)

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ClinicalTrials.gov Identifier: NCT02862639
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.


Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Device: Experimental group Device: control group Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip
Study Start Date : February 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: injection of viscosupplementation and corticosteroid
experimental group
Device: Experimental group
patient receive intra articular injection (hip joint) of viscosupplementation in combination with corticosteroid

Active Comparator: injection of corticosteroid
control group
Device: control group
patient receive intra articular injection (hip joint) of corticosteroid alone




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862639


Locations
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France
Chu de Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02862639    
Other Study ID Numbers: PA12069
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: September 2016
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases