Total Hip ReplacementPOLYTITANNCT02524587
Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement
A study testing standard polyethylene acetabular irradiated at 3 Mrad, radio stereometric analysis (RSA) of the acetabular and acetabular polyethylene vitamys® in people with Total Hip Replacement, run by University Hospital, Caen at 1 site in France.
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. However, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- standard polyethylene acetabular irradiated at 3 Mrad, radio stereometric analysis (RSA) of the acetabular and acetabular polyethylene vitamys®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Nov 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged men and women 18 to 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
- pregnant or desiring to be for the duration of the study
- minors or adults protected
- repeated hip replacement
- cephalic prosthesis recovery or intermediate
- repeated cupules
- primary or secondary malignant tumor of the hip
Trial locations and contacts
1 site in 1 country.
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, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.
- Conditions
- Total Hip Replacement
- Being tested
- standard polyethylene acetabular irradiated at 3 Mrad, radio stereometric analysis (RSA) of the acetabular, acetabular polyethylene vitamys®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard polyethylene acetabular irradiated at 3 MradDevice
radio stereometric analysis (RSA) of the acetabularOther
acetabular polyethylene vitamys®Device
| Study group | Role | What they receive |
|---|---|---|
| acetabular polyethylene vitamys® | Active comparator | acetabular polyethylene vitamys® Receives: Other: radio stereometric analysis (RSA) of the acetabular; Device: acetabular polyethylene vitamys® |
| standard polyethylene acetabular irradiated at 3 Mrad | Active comparator | standard polyethylene acetabular irradiated at 3 Mrad Receives: Device: standard polyethylene acetabular irradiated at 3 Mrad; Other: radio stereometric analysis (RSA) of the acetabular |
What is being measured
The primary outcome is the main question the study is designed to answer.
penetration of the metal femoral head in acetabular
head penetration in milimeters
Measured: 2 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 startJan 2010
- Primary completionNov 2016
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT02524587
- Sponsor's protocol ID
- 09-113
- Acronym
- POLYTITAN
- Status last verified
- Sep 2018
- First submitted
- 6 Aug 2015
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Rochcongar G, Remazeilles M, Bourroux E, Dunet J, Chapus V, Feron M, Praz C, Buia G, Hulet C. Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial. Acta Orthop. 2021 Apr;92(2):151-155. doi: 10.1080/17453674.2020.1852785. Epub 2020 Dec 2.
PubMed 33263447
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement
- ClinicalTrials.gov ID
- NCT02524587
- Acronym / sponsor ID
- POLYTITAN / 09-113
- Conditions
- Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2022 (estimated)
- 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, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetabular polyethylene vitamys® | Active comparator | Other: radio stereometric analysis (RSA) of the acetabular, Device: acetabular polyethylene vitamys®acetabular polyethylene vitamys® |
| standard polyethylene acetabular irradiated at 3 Mrad | Active comparator | Device: standard polyethylene acetabular irradiated at 3 Mrad, Other: radio stereometric analysis (RSA) of the acetabularstandard polyethylene acetabular irradiated at 3 Mrad |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged men and women 18 to 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 (7 listed)
- patients aged 76 years or more
- pregnant or desiring to be for the duration of the study
- minors or adults protected
- repeated hip replacement
- cephalic prosthesis recovery or intermediate
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 |
|---|---|---|
| standard polyethylene acetabular irradiated at 3 Mrad | Device | standard polyethylene acetabular irradiated at 3 Mrad |
| radio stereometric analysis (RSA) of the acetabular | Other | acetabular polyethylene vitamys®, standard polyethylene acetabular irradiated at 3 Mrad |
| acetabular polyethylene vitamys® | Device | acetabular polyethylene vitamys® |
Primary outcome
penetration of the metal femoral head in acetabular
Time frame: 2 years
head penetration in milimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 33263447Rochcongar G, Remazeilles M, Bourroux E, Dunet J, Chapus V, Feron M, Praz C, Buia G, Hulet C. Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial. Acta Orthop. 2021 Apr;92(2):151-155. doi: 10.1080/17453674.2020.1852785. Epub 2020 Dec 2.
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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 study testing standard polyethylene acetabular irradiated at 3 Mrad, radio stereometric analysis (RSA) of the acetabular and acetabular polyethylene vitamys® in people with Total Hip Replacement, run by University Hospital, Caen 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Sep 2018. 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.
Are results available for this study?
Results are not available in the source record.
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?
penetration of the metal femoral head in acetabular (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524587, which also lists 1 linked publication.
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 11 Sep 2018.