Removal Wichita Fusion Nail After Knee ArthrodesisNCT02045615
Removal Wichita Fusion Nail After Knee Arthrodesis
An observational study of Removal Wichita Fusion Nail After Knee Arthrodesis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to make clear how difficult it is to remove osteosynthesis materials afterwards, so surgeons will think twice before inserting intramedullary nails. Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has become. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Removal Wichita Fusion Nail After Knee Arthrodesis
- What is being tested?
- Proposed technique for removal of the Wichita Fusion Nail
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to Jul 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had to have their Wichita Fusion Nail extracted
Who may be able to join
- Extraction of Wichita Fusion Nail
Who cannot join
- All other kinds of intramedullairy nails used to become a solid knee arhrodesis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to make clear how difficult it is to remove osteosynthesis materials afterwards, so surgeons will think twice before inserting intramedullary nails. Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has become.
- Being tested
- Proposed technique for removal of the Wichita Fusion Nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proposed technique for removal of the Wichita Fusion NailProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Conventional technique for Wichita nail extraction | |
| New | Proposed technique for Wichita nail extraction Receives: Procedure: Proposed technique for removal of the Wichita Fusion Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation technique
Was the arthrodesis site left intact? How was the Nail removed? Time for operation?
Measured: first 4 months postop
Secondary outcomes (3)
Mobility
Measured: 1 year postop
Pain measurement following the Visual Analogue Scale
Measured: 1 year postop
Major complications after removal
Amputation? Infection? Wound problems?
Measured: first 2 years postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Removal Wichita Fusion Nail After Knee ArthrodesisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045615
- Sponsor's protocol ID
- S56066
- Status last verified
- Nov 2020
- First submitted
- 21 Jan 2014
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal Wichita Fusion Nail After Knee Arthrodesis
- ClinicalTrials.gov ID
- NCT02045615
- Acronym / sponsor ID
- S56066
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Jan 2014 (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 study is to make clear how difficult it is to remove osteosynthesis materials afterwards, so surgeons will think twice before inserting intramedullary nails. Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has become.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | – | –Conventional technique for Wichita nail extraction |
| New | – | Procedure: Proposed technique for removal of the Wichita Fusion NailProposed technique for Wichita nail extraction |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had to have their Wichita Fusion Nail extracted
Key inclusion criteria (1 listed)
- Extraction of Wichita Fusion Nail
Key exclusion criteria (1 listed)
- All other kinds of intramedullairy nails used to become a solid knee arhrodesis
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 |
|---|---|---|
| Proposed technique for removal of the Wichita Fusion Nail | Procedure or surgery | New |
Primary outcome
Operation technique
Time frame: first 4 months postop
Was the arthrodesis site left intact? How was the Nail removed? Time for operation?
3 secondary outcomes
Mobility
Time frame: 1 year postop
Pain measurement following the Visual Analogue Scale
Time frame: 1 year postop
Major complications after removal
Time frame: first 2 years postop
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 18 Nov 2020.
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 Removal Wichita Fusion Nail After Knee Arthrodesis, run by Universitaire Ziekenhuizen KU Leuven 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 18 Nov 2020. 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?
Operation technique (time frame: first 4 months postop). 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 18 Nov 2020.