Hip OsteoarthritisPhase 3VISCOSUPP-HIPNCT02862639
Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip
A Phase 3 study testing Experimental group in people with Hip Osteoarthritis, run by CHU de Reims at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Experimental group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Experimental group, control group
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupDevice
patient receive intra articular injection (hip joint) of viscosupplementation in combination with corticosteroid
control groupDevice
patient receive intra articular injection (hip joint) of corticosteroid alone
| Study group | Role | What they receive |
|---|---|---|
| injection of viscosupplementation and corticosteroid | Experimental | experimental group Receives: Device: Experimental group |
| injection of corticosteroid | Active comparator | control group Receives: Device: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
improving pain
decrease of 20 mm on a visual analog pain scale between the evaluation at day 0 and the evaluation at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862639
- Sponsor's protocol ID
- PA12069
- Acronym
- VISCOSUPP-HIP
- Status last verified
- Sep 2016
- First submitted
- 8 Aug 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip
- ClinicalTrials.gov ID
- NCT02862639
- Acronym / sponsor ID
- VISCOSUPP-HIP / PA12069
- Conditions
- Hip Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injection of viscosupplementation and corticosteroid | Experimental | Device: Experimental groupexperimental group |
| injection of corticosteroid | Active comparator | Device: control groupcontrol group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental grouppatient receive intra articular injection (hip joint) of viscosupplementation in combination with corticosteroid | Device | injection of viscosupplementation and corticosteroid |
| control grouppatient receive intra articular injection (hip joint) of corticosteroid alone | Device | injection of corticosteroid |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental group in people with Hip Osteoarthritis, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improving pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.