Elbow FractureNCT04634305
Clinical and Functional Results After Total Elbow Arthroplasty
An observational study of Elbow Fracture and Elbow Arthropathy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months The hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Fracture, Elbow Arthropathy, Elbow Osteoarthritis
- What is being tested?
- Total elbow arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2004to 31 Dec 2021
- How long will I take part?
- 72 Months
- 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
- Adult, Older adult
Study population: Every patient that underwent a total elbow arthroplasty between january 2004 and august 2020 by a single operator in our orthopedic center
Who may be able to join
- Total elbow arthroplasty, all indication combined
Who cannot join
- Less than 24 months of follow up
- Revision of total elbow arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical and Functional Results Obtained After a Total Elbow Arthroplasty, All Indications Combined
Analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months The hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is
- Conditions
- Elbow Fracture, Elbow Arthropathy, Elbow Osteoarthritis
- Being tested
- Total elbow arthroplasty
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total elbow arthroplastyProcedure or surgery
Total elbow arthroplasty by a single operator
| Study group | Role | What they receive |
|---|---|---|
| Total elbow arthroplasty | Total elbow arthroplasty, all indications combined Receives: Procedure: Total elbow arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Elbow Performance Score
Measured: through study completion, an average of 5 years
QuickDASH
Measured: through study completion, an average of 5 years
Range of motion
Measured: through study completion, an average of 5 years
Secondary outcomes (3)
Implant loosening
Radiolucent lines around the implant on the X Ray
Measured: through study completion, an average of 5 years
Triceps deficiency
Measured: through study completion, an average of 5 years
Bushing wear
Measure of an angle on the X Ray
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Jan 2004
- Primary completion1 Feb 2006
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FractureStudies 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
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 72 Months
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François SIRVEAUX, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634305
- Sponsor's protocol ID
- 2020PI204
- Status last verified
- May 2021
- First submitted
- 18 Oct 2020
- Last updated
- 21 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Functional Results Obtained After a Total Elbow Arthroplasty, All Indications Combined
- ClinicalTrials.gov ID
- NCT04634305
- Acronym / sponsor ID
- 2020PI204
- Conditions
- Elbow Fracture, Elbow Arthropathy, Elbow Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 1 Feb 2006 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Nov 2020 (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.
Analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months The hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 72 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total elbow arthroplasty | – | Procedure: Total elbow arthroplastyTotal elbow arthroplasty, all indications combined |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Every patient that underwent a total elbow arthroplasty between january 2004 and august 2020 by a single operator in our orthopedic center
Key inclusion criteria (1 listed)
- Total elbow arthroplasty, all indication combined
Key exclusion criteria (2 listed)
- Less than 24 months of follow up
- Revision of total elbow arthroplasty
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 elbow arthroplastyTotal elbow arthroplasty by a single operator | Procedure or surgery | Total elbow arthroplasty |
Primary outcome
Mayo Elbow Performance Score
Time frame: through study completion, an average of 5 years
QuickDASH
Time frame: through study completion, an average of 5 years
Range of motion
Time frame: through study completion, an average of 5 years
3 secondary outcomes
Implant loosening
Time frame: through study completion, an average of 5 years
Triceps deficiency
Time frame: through study completion, an average of 5 years
Bushing wear
Time frame: through study completion, an average of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Undecided
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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 Elbow Fracture and Elbow Arthropathy, 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 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 21 May 2021. 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?
Mayo Elbow Performance Score (time frame: through study completion, an average of 5 years). The study lists 3 primary outcomes in all. 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 21 May 2021.