Calcaneocuboid Osteoarthritis Secondary to TraumaNCT06003296
Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial
A study testing Calcaneocuboid arthrodesis in people with Calcaneocuboid Osteoarthritis Secondary to Trauma, run by Assiut University at 1 site in Egypt.
Trial summary
Investigators aim to compare clinical and radiological outcome of use of plate versus screw fixation for calcaneocuboid arthrodesis in adult population. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Calcaneocuboid Osteoarthritis Secondary to Trauma
- What is being tested?
- Calcaneocuboid arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 1 Aug 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients who will be operated by calcaneocuboid fusion for any indication age range 18-65 no paralytic patients
Who cannot join
- age < 18 , > 65 acute calcaneal fracture infection non union bone defect that need bone graft refusing to participate in the study neuropathic patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut
Abdelrazik Talaat, 01015828696, Abdelraziktalaat@med.aun.edu.eg
About this study
Investigators aim to compare clinical and radiological outcome of use of plate versus screw fixation for calcaneocuboid arthrodesis in adult population.
Read the detailed description
The calcaneocuboid joint is stable, even although multiple conditions might affect the joint, ranging from osteoarthritis to fracture, subluxation, and dislocation. Calcaneocuboid arthrodesis is more commonly performed as an adjunct procedure with other rearfoot procedures such as triple arthrodesis and is less used as isolated fusion.[1],[2],[3] What the most effective and least cost method for calcaneocuboid arthrodesis?! Many conditions that may affect foot that cause pain ; and there are many methods for relieve that pain , one of these is arthrodesis , and calcaneocuboid joint one of the most affected joints , and commonly we do calcaneocuboid arthrodesis as a part of triple arthrodesis ( subtalar , talonavicular , calcaneocuboid ); The traditional fixation for a calcaneocuboid (CC) arthrodesis in triple arthrodesis is with a 6.5-mm cancellous screw. This procedure can be technically challenging. Fixation with a locking compression plate (LCP) may be easier to perform while achieving compression perpendicular to the fusion site. Investigators suppose that plate is more powerful than screw in calcaneocuboid arthrodesis. The purpose of this study was to compare the load to failure and the stiffness for each fixation method. [4],[5],[6] literature reveal that: More stability to the fusion site can be applied by using plate fixation. Rationale of the research that: calcaneocuboid arthrodesis with screw is effective and least cost compare to plate fixation? [7]
- Being tested
- Calcaneocuboid arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcaneocuboid arthrodesisProcedure or surgery
Calcaneocuboid arthrodesis in triple arthrodesis
| Study group | Role | What they receive |
|---|---|---|
| Screw fixation | Other | Calcaneocuboid arthrodesis in triple arthrodesis by Screw fixation Receives: Procedure: Calcaneocuboid arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess calcaneocuboid arthrodesis union
calcaneocuboid arthrodesis union by RUST score
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start10 Sep 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneocuboid Osteoarthritis Secondary to TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrazik Talaat Abdelrazik Khalifa, Assiut University
- Investigators
- Abdelrazik Talaat, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003296
- Sponsor's protocol ID
- Calcaneocuboid arthrodesis
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06003296
- Acronym / sponsor ID
- Calcaneocuboid arthrodesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 21 Aug 2023 (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.
Investigators aim to compare clinical and radiological outcome of use of plate versus screw fixation for calcaneocuboid arthrodesis in adult population.
Detailed description
The calcaneocuboid joint is stable, even although multiple conditions might affect the joint, ranging from osteoarthritis to fracture, subluxation, and dislocation. Calcaneocuboid arthrodesis is more commonly performed as an adjunct procedure with other rearfoot procedures such as triple arthrodesis and is less used as isolated fusion.[1],[2],[3] What the most effective and least cost method for calcaneocuboid arthrodesis?! Many conditions that may affect foot that cause pain ; and there are many methods for relieve that pain , one of these is arthrodesis , and calcaneocuboid joint one of the most affected joints , and commonly we do calcaneocuboid arthrodesis as a part of triple arthrodesis ( subtalar , talonavicular , calcaneocuboid ); The traditional fixation for a calcaneocuboid (CC) arthrodesis in triple arthrodesis is with a 6.5-mm cancellous screw. This procedure can be technically challenging. Fixation with a locking compression plate (LCP) may be easier to perform while achieving compression perpendicular to the fusion site. Investigators suppose that plate is more powerful than screw in calcaneocuboid arthrodesis. The purpose of this study was to compare the load to failure and the stiffness for each fixation method. [4],[5],[6] literature reveal that: More stability to the fusion site can be applied by using plate fixation. Rationale of the research that: calcaneocuboid arthrodesis with screw is effective and least cost compare to plate fixation? [7]
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screw fixation | Other | Procedure: Calcaneocuboid arthrodesisCalcaneocuboid arthrodesis in triple arthrodesis by Screw fixation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients who will be operated by calcaneocuboid fusion for any indication age range 18-65 no paralytic patients
Key exclusion criteria (1 listed)
- age < 18 , > 65 acute calcaneal fracture infection non union bone defect that need bone graft refusing to participate in the study neuropathic patients
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 |
|---|---|---|
| Calcaneocuboid arthrodesisCalcaneocuboid arthrodesis in triple arthrodesis | Procedure or surgery | Screw fixation |
Primary outcome
Assess calcaneocuboid arthrodesis union
Time frame: One year
calcaneocuboid arthrodesis union by RUST score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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.
Abdelrazik Talaat principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcaneocuboid arthrodesis in people with Calcaneocuboid Osteoarthritis Secondary to Trauma, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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 Egypt. 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?
Contact Abdelrazik Talaat (01015828696, Abdelraziktalaat@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess calcaneocuboid arthrodesis union (time frame: One year). 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 Aug 2023.