Back to resultsEfficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip (VISCOSUPP-HIP)
Primary Purpose
Hip Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Experimental group
control group
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis
Eligibility 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
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
injection of viscosupplementation and corticosteroid
injection of corticosteroid
Arm Description
experimental group
control group
Outcomes
Primary Outcome Measures
improving pain
decrease of 20 mm on a visual analog pain scale between the evaluation at day 0 and the evaluation at 3 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02862639
Brief Title
Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip
Acronym
VISCOSUPP-HIP
Official Title
Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
injection of viscosupplementation and corticosteroid
Arm Type
Experimental
Arm Description
experimental group
Arm Title
injection of corticosteroid
Arm Type
Active Comparator
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
Experimental group
Intervention Description
patient receive intra articular injection (hip joint) of viscosupplementation in combination with corticosteroid
Intervention Type
Device
Intervention Name(s)
control group
Intervention Description
patient receive intra articular injection (hip joint) of corticosteroid alone
Primary Outcome Measure Information:
Title
improving pain
Description
decrease of 20 mm on a visual analog pain scale between the evaluation at day 0 and the evaluation at 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip
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