Big Toe ProsthesisNCT00284375
Systematic Registration of All Big Toe Prostheses Placed in Ghent University Hospital
An observational study of Big Toe Prosthesis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Systematic registration of all big toe prostheses placed in Ghent University Hospital for analyses of global results, comparison between different types of prostheses, ... Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Big Toe Prosthesis
- What is being tested?
- Registration of all big toe prostheses in Ghent University Hospital
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2005to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 500 patients will be included.
Who may be able to join
- Big toe prosthesis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Systematic registration of all big toe prostheses placed in Ghent University Hospital for analyses of global results, comparison between different types of prostheses, ...
- Conditions
- Big Toe Prosthesis
- Being tested
- Registration of all big toe prostheses in Ghent University Hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registration of all big toe prostheses in Ghent University HospitalProcedure or surgery
Registration of all big toe prostheses in Ghent University Hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of big toe prostheses.
Developing a database of all big toe prostheses in Ghent University Hospital.
Measured: ongoing basis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startJan 2005
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Big Toe ProsthesisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim Bongaerts, MD, Principal investigator, University Hospital, GhentJeroen De Vil, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284375
- Sponsor's protocol ID
- 2005/016
- Status last verified
- Dec 2022
- First submitted
- 30 Jan 2006
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Registration of All Big Toe Prostheses Placed in Ghent University Hospital
- ClinicalTrials.gov ID
- NCT00284375
- Acronym / sponsor ID
- 2005/016
- Conditions
- Big Toe Prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Jan 2006 (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.
Systematic registration of all big toe prostheses placed in Ghent University Hospital for analyses of global results, comparison between different types of prostheses, ...
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 500 patients will be included.
Key inclusion criteria (1 listed)
- Big toe prosthesis
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Registration of all big toe prostheses in Ghent University HospitalRegistration of all big toe prostheses in Ghent University Hospital. | Procedure or surgery | – |
Primary outcome
Frequency of big toe prostheses.
Time frame: ongoing basis
Developing a database of all big toe prostheses in Ghent University Hospital.
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 8 Dec 2022.
- Website University Hospital GhentLink provided by the sponsor.
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.
Wim Bongaerts, MD principal investigator
University Hospital, Ghent
Jeroen De Vil, MD principal investigator
University Hospital, Ghent
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 Big Toe Prosthesis, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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 8 Dec 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 Belgium. 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?
Frequency of big toe prostheses. (time frame: ongoing basis). 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 8 Dec 2022.