Aseptic LooseningPTHNCT03680443
Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement
An observational study of Aseptic Loosening and Arthroplasty Complications, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been… Read more about this study
- Who is it for?
- Ages 19 to 94 years
- Conditions the study is for
- Aseptic Loosening, Arthroplasty Complications
- What is being tested?
- assembly in THA revision
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2013to 26 Apr 2017
- Phase
- Observational
- 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 19 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.
Who may be able to join
- patients between 19 and 84 years
- patients receiving such an assembly in THA revision
Who cannot join
- <19years
- > 94 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement: A 62 Case Series at a Minimum 5 Years Follow-up
Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.
The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.
A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up.
Read the detailed description
Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.
The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.
A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.
- Conditions
- Aseptic Loosening, Arthroplasty Complications
- Being tested
- assembly in THA revision
- Keywords
- revision, reinforcement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assembly in THA revisionOther
A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.
What is being measured
The primary outcome is the main question the study is designed to answer.
dual-mobility cup cemented (effectiveness in terms of aseptic loosening)
The objective of the present study is to evaluate the most effective type of assembly , dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening in the prevention of dislocation during the revision of the total hip arthroplasty (THA)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 Jan 2013
- Primary completion26 Apr 2017
- Study completion26 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aseptic LooseningStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice MERTL, MD, PhD, Principal investigator, CHU AMIENS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680443
- Sponsor's protocol ID
- PI2017_843_0041
- Acronym
- PTH
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement: A 62 Case Series at a Minimum 5 Years Follow-up
- ClinicalTrials.gov ID
- NCT03680443
- Acronym / sponsor ID
- PTH / PI2017_843_0041
- Conditions
- Aseptic Loosening, Arthroplasty Complications
- Keywords
- revision, reinforcement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 21 Sep 2018 (actual)
- 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.
Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.
The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.
A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up.
Detailed description
Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.
The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.
A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.
Key inclusion criteria (2 listed)
- patients between 19 and 84 years
- patients receiving such an assembly in THA revision
Key exclusion criteria (2 listed)
- <19years
- > 94 years
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 |
|---|---|---|
| assembly in THA revisionA single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed. | Other | – |
Primary outcome
dual-mobility cup cemented (effectiveness in terms of aseptic loosening)
Time frame: 5 years
The objective of the present study is to evaluate the most effective type of assembly , dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening in the prevention of dislocation during the revision of the total hip arthroplasty (THA)
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 16 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Patrice MERTL, MD, PhD principal investigator
CHU AMIENS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aseptic Loosening and Arthroplasty Complications, run by Centre Hospitalier Universitaire, Amiens 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 2 inclusion and 2 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 16 Jun 2026. 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?
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?
dual-mobility cup cemented (effectiveness in terms of aseptic loosening) (time frame: 5 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 16 Jun 2026.