Wrist SurgeryNCT00284310
Follow-up of Patients After 4-row Arthrodesis or Proximal Row Carpectomy
A study testing Anamnesis and clinical examination in people with Wrist Surgery, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The purpose of this trial is to follow-up on patients who underwent different types of wrist surgery: 4-row arthrodesis or proximal row carpectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Surgery
- What is being tested?
- Anamnesis and clinical examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2005to Dec 2008
- Phase
- Interventional
- 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
Who may be able to join
- All patients who underwent wrist surgery (4-row arthrodesis or proximal row carpectomy) between 1998 and 2004
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to follow-up on patients who underwent different types of wrist surgery: 4-row arthrodesis or proximal row carpectomy.
- Conditions
- Wrist Surgery
- Being tested
- Anamnesis and clinical examination
- Keywords
- Wrist surgery: 4-corner arthrodesis or proximal row carpectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anamnesis and clinical examinationProcedure or surgery
Anamnesis and clinical examination to follow.
| Study group | Role | What they receive |
|---|---|---|
| wrist surgery | Experimental | Not described Receives: Procedure: Anamnesis and clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of both types of wrist surgery
Measured: 5 to 10 years follow up
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 startOct 2005
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rene Verdonk, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284310
- Sponsor's protocol ID
- 2005/183
- Status last verified
- Dec 2014
- First submitted
- 30 Jan 2006
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Patients After 4-row Arthrodesis or Proximal Row Carpectomy
- ClinicalTrials.gov ID
- NCT00284310
- Acronym / sponsor ID
- 2005/183
- Conditions
- Wrist Surgery
- Keywords
- Wrist surgery: 4-corner arthrodesis or proximal row carpectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2005 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (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.
The purpose of this trial is to follow-up on patients who underwent different types of wrist surgery: 4-row arthrodesis or proximal row carpectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wrist surgery | Experimental | Procedure: Anamnesis and clinical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who underwent wrist surgery (4-row arthrodesis or proximal row carpectomy) between 1998 and 2004
Key exclusion criteria (0 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 |
|---|---|---|
| Anamnesis and clinical examinationAnamnesis and clinical examination to follow. | Procedure or surgery | wrist surgery |
Primary outcome
Results of both types of wrist surgery
Time frame: 5 to 10 years 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 20 Dec 2022.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Rene Verdonk, MD, PhD 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?
A study testing Anamnesis and clinical examination in people with Wrist Surgery, 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 0 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 20 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?
Results of both types of wrist surgery (time frame: 5 to 10 years 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 20 Dec 2022.