TantalumNCT05510011
Allograft and Tantalum Cone Reconstruction in TKA Revision
An observational study of Tantalum and Bone Loss, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A new surgical technique of reconstruction for bone loss in TKA revision using tantalum cone and allograft. Study of radiological and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 21 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women attending for 3rd timester scan
Who may be able to join
- > 18 years old
- TKA revision using tantalum cone or allograft
Who cannot join
- <18 years old
- no reconstruction used in TKA revision
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Louis DAGNEAUX, PHU, 06 99 42 24 90 ext. 33, l-dagneaux@chu-montpellier.fr
About this study
Official title: Clinical and Radiological Outcomes of Composite Tibial and Femoral Allograft and Tantalum Cone Reconstructions in Total Knee Replacement Revision
A new surgical technique of reconstruction for bone loss in TKA revision using tantalum cone and allograft.
Study of radiological and clinical outcomes.
- Keywords
- Tantalum, Allograft, TKA revision using tantalum cone and/or allograft
- Medical subject headings
- Bone Diseases, Metabolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Survivorship of the implant
Survivorship of the implant
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Jan 2022
- Primary completion20 Feb 2023 (estimated)
- Study completion21 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TantalumStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis DAGNEAUX, PHU, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510011
- Sponsor's protocol ID
- RECHMPL22_0013
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Outcomes of Composite Tibial and Femoral Allograft and Tantalum Cone Reconstructions in Total Knee Replacement Revision
- ClinicalTrials.gov ID
- NCT05510011
- Acronym / sponsor ID
- RECHMPL22_0013
- Keywords
- Tantalum, Allograft, TKA revision using tantalum cone and/or allograft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Feb 2023 (estimated)
- Study completion
- 21 Feb 2023 (estimated)
- First posted
- 22 Aug 2022 (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.
A new surgical technique of reconstruction for bone loss in TKA revision using tantalum cone and allograft.
Study of radiological and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women attending for 3rd timester scan
Key inclusion criteria (2 listed)
- > 18 years old
- TKA revision using tantalum cone or allograft
Key exclusion criteria (2 listed)
- <18 years old
- no reconstruction used in TKA revision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Survivorship of the implant
Time frame: day 1
Survivorship of the implant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: Undecided. NC
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.
Louis DAGNEAUX, PHU study director
University Hospital, Montpellier
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 Tantalum and Bone Loss, run by University Hospital, Montpellier 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. 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?
Contact Louis DAGNEAUX, PHU (04 67 33 09 80 ext. 33, f-fuchs@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Survivorship of the implant (time frame: day 1). 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 22 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.