Fracture of the AnkleNCT00284349
Study to Investigate the Added Value of a Rehabilitation Brace in the Treatment at Home After a Fracture of the Ankle
A study testing Use of a rehabilitation brace instead of a plaster in people with Fracture of the Ankle, run by University Hospital, Ghent.
Trial summary
Comparison between immobilisation by a plaster and a rehabilitation brace for the treatment of a fracture of the ankle Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of the Ankle
- What is being tested?
- Use of a rehabilitation brace instead of a plaster
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Fracture of the ankle
Who cannot join
- -
About this study
Comparison between immobilisation by a plaster and a rehabilitation brace for the treatment of a fracture of the ankle
- Conditions
- Fracture of the Ankle
- Being tested
- Use of a rehabilitation brace instead of a plaster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a rehabilitation brace instead of a plasterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility of the ankle
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of the AnkleStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Rene Verdonk, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284349
- Sponsor's protocol ID
- 2005/043
- Status last verified
- Jul 2021
- First submitted
- 30 Jan 2006
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Added Value of a Rehabilitation Brace in the Treatment at Home After a Fracture of the Ankle
- ClinicalTrials.gov ID
- NCT00284349
- Acronym / sponsor ID
- 2005/043
- Conditions
- Fracture of the Ankle
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- 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.
Comparison between immobilisation by a plaster and a rehabilitation brace for the treatment of a fracture of the ankle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fracture of the ankle
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 |
|---|---|---|
| Use of a rehabilitation brace instead of a plaster | Device | – |
Primary outcome
Mobility of the ankle
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Website University Hospital GhentLink provided by the sponsor.
Related trials for Fracture of the Ankle
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
Active, not recruitingObservational study
Turkish Version of the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM-TR): A Multi-Centre Validation Study
Ankle Fractures, Ankle Injuries
Not yet recruiting
Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
Ankle Fractures, Syndesmotic Injury of the Ankle
Not yet recruiting
Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
Open Tibia Fracture, Open Dislocation of Ankle
Recruiting
Accelerated Flap Coverage in Severe Lower Extremity Trauma
Open Tibia Fracture, Open Dislocation of Ankle
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
Questions about this trial
What is this clinical trial studying?
A study testing Use of a rehabilitation brace instead of a plaster in people with Fracture of the Ankle, run by University Hospital, Ghent.
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: withdrawn, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Mobility of the ankle. 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 2 Jul 2021.