Fragility Ankle Fractures and Complex Distal Tibial FracturesNCT06709365
Tibio-talo-calcaneal Fusion by Hindfoot Nail Versus Open Reduction and Internal Fixation in Treatment of Complex Fractures Distal Tibial and Fragility Ankle Fractures in Elderly
A study testing Tibiotalar calcaneal fusion by hindfoot in people with Fragility Ankle Fractures and Complex Distal Tibial Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
Tibiotalar calcaneal fusion by hindfoot nail Vs open reduction and internal fixation in treatment of complex distal tibial fractures and ankle fragility ankle fractures in elderly Read more about this study
- Who is it for?
- Ages 1 year to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Fragility Ankle Fractures and Complex Distal Tibial Fractures
- What is being tested?
- Tibiotalar calcaneal fusion by hindfoot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2024to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- pilon fractures complex distal tibial fractures ankle comminuted fractures age more than 65yrs osteoprotic fractures surgically fit patients
Who cannot join
- Ankle fractures unimalleolar undisplaced Pathological fractures Young adults DVT Peripheral vascular diseases Age less than 65 Unfit patient for surgery
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed S Shaker, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospitals
Sohag
Magdi M Amin
About this study
Tibiotalar calcaneal fusion by hindfoot nail Vs open reduction and internal fixation in treatment of complex distal tibial fractures and ankle fragility ankle fractures in elderly
- Being tested
- Tibiotalar calcaneal fusion by hindfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibiotalar calcaneal fusion by hindfootProcedure or surgery
Hindfoot nail for ankle fusion
| Study group | Role | What they receive |
|---|---|---|
| Fusion group | Active comparator | Not described Receives: Procedure: Tibiotalar calcaneal fusion by hindfoot |
| Open reduction and internal fixation group | Active comparator | Not described Receives: Procedure: Tibiotalar calcaneal fusion by hindfoot |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS American orthopedic foot and ankle score (Score for clinical effects of our intervention)
Score for clinical effects of our intervention
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fragility Ankle Fractures and Complex Distal Tibial FracturesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdelgawad Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709365
- Sponsor's protocol ID
- Soh-Med-24-11-4MD
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sorour YO, Mahmoud AAG, Shaker AS, Salama WA. Tibiotalocalcaneal Fusion Using Hindfoot Nailing Versus Open Reduction and Internal Fixation for Fragility Ankle Fractures in Older Adults: A Prospective Randomized Comparative Study. Orthop Traumatol Surg Res. 2026 Nov 3:104984. doi: 10.1016/j.otsr.2026.104984. Online ahead of print.
PubMed 42977155
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tibio-talo-calcaneal Fusion by Hindfoot Nail Versus Open Reduction and Internal Fixation in Treatment of Complex Fractures Distal Tibial and Fragility Ankle Fractures in Elderly
- ClinicalTrials.gov ID
- NCT06709365
- Acronym / sponsor ID
- Soh-Med-24-11-4MD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 29 Nov 2024 (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.
Tibiotalar calcaneal fusion by hindfoot nail Vs open reduction and internal fixation in treatment of complex distal tibial fractures and ankle fragility ankle fractures in elderly
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fusion group | Active comparator | Procedure: Tibiotalar calcaneal fusion by hindfoot |
| Open reduction and internal fixation group | Active comparator | Procedure: Tibiotalar calcaneal fusion by hindfoot |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pilon fractures complex distal tibial fractures ankle comminuted fractures age more than 65yrs osteoprotic fractures surgically fit patients
Key exclusion criteria (2 listed)
- Ankle fractures unimalleolar undisplaced Pathological fractures Young adults DVT Peripheral vascular diseases Age less than 65 Unfit patient for surgery
- -
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 |
|---|---|---|
| Tibiotalar calcaneal fusion by hindfootHindfoot nail for ankle fusion | Procedure or surgery | Fusion group, Open reduction and internal fixation group |
Primary outcome
AOFAS American orthopedic foot and ankle score (Score for clinical effects of our intervention)
Time frame: 2years
Score for clinical effects of our intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 42977155Sorour YO, Mahmoud AAG, Shaker AS, Salama WA. Tibiotalocalcaneal Fusion Using Hindfoot Nailing Versus Open Reduction and Internal Fixation for Fragility Ankle Fractures in Older Adults: A Prospective Randomized Comparative Study. Orthop Traumatol Surg Res. 2026 Nov 3:104984. doi: 10.1016/j.otsr.2026.104984. Online ahead of print.
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.
Ahmed S Shaker, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibiotalar calcaneal fusion by hindfoot in people with Fragility Ankle Fractures and Complex Distal Tibial Fractures, run by Sohag 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 2 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amr A Mahmoud, Assistant lecturer (01066180172, Amr.abdelgawad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS American orthopedic foot and ankle score (Score for clinical effects of our intervention) (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06709365, which also lists 1 linked publication.
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 29 Nov 2024.