Arthroplasty ComplicationsNCT05969366
Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor
An observational study of Arthroplasty Complications, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Retrospective, single-centre study. Review of patients aged 85 and over who underwent total hip replacement between June 2015 and February 2022. This is a femoral stem survival study with calculation of the complication rate in this population. Read more about this study
- Who is it for?
- Ages 85 years and older
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jul 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 85 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Any people of 85 years of more who received total hip arthroplasty with uncemented stem fully hydroxyapatitis coated
Who may be able to join
- receive total hip arthroplasty with uncemented stem fully hydroxyapatites coated
Who cannot join
- trauma context
- less than 3 month follow up
- Any surgery of the hip as medical history
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective, single-centre study. Review of patients aged 85 and over who underwent total hip replacement between June 2015 and February 2022.
This is a femoral stem survival study with calculation of the complication rate in this population.
The study does not focus on total hip replacements in the context of trauma. The secondary endpoint was the search for complication risk factors.
- Conditions
- Arthroplasty Complications
- Being tested
- Total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem | Not described Receives: Procedure: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of complication
survival study, any complications
Measured: minimum of 3 months follow up
Secondary outcomes (1)
risk factor of complications
Measured: minimum of 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startJun 2015
- Primary completionApr 2016
- Study completionJul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier ROCHE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969366
- Sponsor's protocol ID
- 2022PI032
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Aug 2023
- 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 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor
- ClinicalTrials.gov ID
- NCT05969366
- Acronym / sponsor ID
- 2022PI032
- Conditions
- Arthroplasty Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2023 (actual)
- First posted
- 1 Aug 2023 (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.
Retrospective, single-centre study. Review of patients aged 85 and over who underwent total hip replacement between June 2015 and February 2022.
This is a femoral stem survival study with calculation of the complication rate in this population.
The study does not focus on total hip replacements in the context of trauma. The secondary endpoint was the search for complication risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem | – | Procedure: Total hip arthroplasty |
Who may qualify
- Ages
- 85 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Any people of 85 years of more who received total hip arthroplasty with uncemented stem fully hydroxyapatitis coated
Key inclusion criteria (1 listed)
- receive total hip arthroplasty with uncemented stem fully hydroxyapatites coated
Key exclusion criteria (3 listed)
- trauma context
- less than 3 month follow up
- Any surgery of the hip as medical history
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 |
|---|---|---|
| Total hip arthroplasty | Procedure or surgery | patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem |
Primary outcome
rate of complication
Time frame: minimum of 3 months follow up
survival study, any complications
1 secondary outcome
risk factor of complications
Time frame: minimum of 3 months follow up
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 Aug 2023.
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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?
An observational study of Arthroplasty Complications, run by Central Hospital, Nancy, France 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 1 inclusion and 3 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 Aug 2023. 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?
rate of complication (time frame: minimum of 3 months follow up). 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 Aug 2023.