Total Hip ReplacementDOUMOBNCT02525809
Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.
A study testing Novae E®, Sunfit® and Quartz® in people with Total Hip Replacement, run by University Hospital, Caen.
Trial summary
The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Novae E®, Sunfit® and Quartz®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Aug 2015
- Phase
- Interventional
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients older men or women 60-75 years
- with a primary or secondary osteoarthritis or osteonecrosis
- having a functional disorder requiring the installation of a total hip prosthesis of primary
Who cannot join
- patients aged 76 years or more
- protected adults
- resumption of PTH
- cephalic prosthesis recovery or intermediate
- resumption of cupules
- primary or secondary malignant tumor of the hip
About this study
The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, observation showed that the dislocation is not a rare complication (2-4%) and the lifetime of the implants is limited due to aseptic loosening.
The evaluation process used in this study will be the extent of penetration of the metal femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA) whose precision provides early results (2 3 years), long before wear and migration are measurable by conventional radiological means. The main objective will be to compare, 2 years after the intervention, the penetration of the metal femoral head in 3 types of inserts: two dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure (Sunfit®), and a fixed insert (Quartz®).
Read more
This is a randomized controlled trial. 105 patients will be enrolled (35 in each group). Patients will be included in each of the two participating centers (Amiens, Caen). The analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will be made to 3 years if the analysis requires it to 2 years.
Analysis of pictures will be centralized in Caen and performed with specific software after transferring images via a secure network.
- Conditions
- Total Hip Replacement
- Being tested
- Novae E®, Sunfit®, Quartz®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novae E®Device
Sunfit®Device
Quartz®Device
| Study group | Role | What they receive |
|---|---|---|
| mobility insert with tripod attachment (Novae E®) | Other | mobility insert with tripod attachment (Novae E®) Receives: Device: Novae E® |
| mobility insert with press fit pure (Sunfit®) | Other | mobility insert with press fit pure (Sunfit®) Receives: Device: Sunfit® |
| fixed insert (Quartz®). | Other | fixed insert (Quartz®). Receives: Device: Quartz® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA)
Measured: change over baseline and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525809
- Sponsor's protocol ID
- 08-114
- Acronym
- DOUMOB
- Status last verified
- Aug 2015
- First submitted
- 13 Aug 2015
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.
- ClinicalTrials.gov ID
- NCT02525809
- Acronym / sponsor ID
- DOUMOB / 08-114
- Conditions
- Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Aug 2015 (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 total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, observation showed that the dislocation is not a rare complication (2-4%) and the lifetime of the implants is limited due to aseptic loosening.
The evaluation process used in this study will be the extent of penetration of the metal femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA) whose precision provides early results (2 3 years), long before wear and migration are measurable by conventional radiological means. The main objective will be to compare, 2 years after the intervention, the penetration of the metal femoral head in 3 types of inserts: two dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure (Sunfit®), and a fixed insert (Quartz®).
This is a randomized controlled trial. 105 patients will be enrolled (35 in each group). Patients will be included in each of the two participating centers (Amiens, Caen). The analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will be made to 3 years if the analysis requires it to 2 years.
Analysis of pictures will be centralized in Caen and performed with specific software after transferring images via a secure network.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mobility insert with tripod attachment (Novae E®) | Other | Device: Novae E®mobility insert with tripod attachment (Novae E®) |
| mobility insert with press fit pure (Sunfit®) | Other | Device: Sunfit®mobility insert with press fit pure (Sunfit®) |
| fixed insert (Quartz®). | Other | Device: Quartz®fixed insert (Quartz®). |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients older men or women 60-75 years
- with a primary or secondary osteoarthritis or osteonecrosis
- having a functional disorder requiring the installation of a total hip prosthesis of primary
Key exclusion criteria (6 listed)
- patients aged 76 years or more
- protected adults
- resumption of PTH
- cephalic prosthesis recovery or intermediate
- resumption of cupules
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 |
|---|---|---|
| Novae E® | Device | mobility insert with tripod attachment (Novae E®) |
| Sunfit® | Device | mobility insert with press fit pure (Sunfit®) |
| Quartz® | Device | fixed insert (Quartz®). |
Primary outcome
Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA)
Time frame: change over baseline and 3 years
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 1 Sep 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Novae E®, Sunfit® and Quartz® in people with Total Hip Replacement, run by University Hospital, Caen.
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 3 inclusion and 6 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA) (time frame: change over baseline and 3 years). 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 1 Sep 2020.