Calcaneus FracturesNCT07423507
Comparative Study Between Internal Fixtion And Primary Subtalar Arthrodesis In Comminuted Intra-Articular Calcaneal Fracture
A study testing Primary Subtalar Arthrodesis and Open reduction and internal fixation in people with Calcaneus Fractures, run by Ahmed Gamal Ibrahim Saleh.
Trial summary
This study is to compare clinical outcome of Sanders type III or IV intra-articular calcaneal fracture treated with open reduction and internal fixation (ORIF) versus ORIF and primary subtalar arthrodesis (PSTA). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Calcaneus Fractures
- What is being tested?
- Primary Subtalar Arthrodesis and Open reduction and internal fixation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 2 Jan 2028
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sanders type 3 and 4 intra articular calcaneal fracture within 14 day of injury
Who cannot join
- patient with open injury, concomitant foot injury, vascular compromise and prior subtalar pathology
About this study
This study is to compare clinical outcome of Sanders type III or IV intra-articular calcaneal fracture treated with open reduction and internal fixation (ORIF) versus ORIF and primary subtalar arthrodesis (PSTA).
Read the detailed description
The calcaneal fractures are the most common tarsal bone fracture, accounting for up to 2% of all fractures in the human body, of which approximately 75% of these fractures are intra-articular.(Almeida, Vale et al. 2022) The calcaneal fractures are serious injuries, often resulting from traumatic axial loading as falls from height or motor vehicle accidents. clinically, it manifests as swelling, pain, ecchymosis, edema of the distal extremity, and an inability to bear weight. Sometimes, anatomical deformity of the hindfoot is noted.(Giuliani, Calori et al. 2025) Radiographic classification of calcaneal fractures is essential for guiding treatment. The Essex-Lopresti classification, one of the oldest reference systems, classifies fractures into tongue type and joint depression-type based on the fracture pattern and orientation of the fracture line. This classification remains important today, particularly for determining surgical approaches and predicting complications.(Essex-Lopresti 1952) Additionally, the Sanders system, currently one of the most widely utilized classification systems for calcaneal fractures, categorizes intra-articular fractures into four types (Type I, II, III, and IV) based on the number and location of fracture lines and fragments.(Sanders 2000, Galluzzo, Greco et al. 2018) Historically, comminuted intra-articular calcaneal fractures were treated nonoperatively, as predictable operative reduction and fixation were not possible. Presently, surgical treatment through ORIF is considered the standard management.(Buckley, Tough et al. 2010, Sanders, Vaupel et al. 2014) Although ORIF has improved clinical and radiological outcomes of comminuted intra-articular calcaneal fractures, Sanders and colleagues reported that fractures involving complications after surgery, proposing primary subtalar arthrodesis (PSA) as alternative.(Eisenstein, Kusnezov et al. 2018, Maccagnano, Noia et al. 2021) Several authors advocate PSA in cases of highly comminuted fractures due to favorable functional results, The management of these fracture patterns is not well established, and the literature remains controversial.(Cianni, Vitiello et al. 2022, Giuliani, Calori et al. 2025).
- Conditions
- Calcaneus Fractures
- Being tested
- Primary Subtalar Arthrodesis, Open reduction and internal fixation
- Keywords
- primary subtalar arthrodesis VS ORIF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Subtalar ArthrodesisProcedure or surgery
Patients undergo primary subtalar arthrodesis via an extended lateral approach. The articular cartilage of the subtalar joint is removed, the calcaneal morphology is restored, and fixation is achieved using cannulated compression screws with a locking plate. Postoperative care follows the same protocol as the ORIF group. This intervention is distinguished from other surgical techniques by performing fusion as the primary treatment in severely comminuted Sanders type III and IV fractures, aiming to reduce the risk of post-traumatic subtalar arthritis.
Open reduction and internal fixationProcedure or surgery
Patients undergo open reduction and internal fixation of displaced intra-articular calcaneal fractures through an extended lateral approach. Fracture reduction is achieved under fluoroscopic guidance, restoring Bohler's and Gissane's angles. Fixation is performed using a locking calcaneal plate with screws. Postoperative care includes immobilization in a cast or splint, non-weight bearing for 8 weeks, followed by a standardized physiotherapy program. This procedure is distinguished from other calcaneal fracture treatments by the use of locking plate technology and precise anatomical reduction for Sanders type III and IV fractures
| Study group | Role | What they receive |
|---|---|---|
| Primary Subtalar Arthrodesis Group | Experimental | Patients with Sanders type III and IV intra-articular calcaneal fractures treated with primary subtalar arthrodesis using cannulated compression screws with plate fixation through an extended lateral approach. Receives: Procedure: Primary Subtalar Arthrodesis |
| Open Reduction and Internal Fixation | Experimental | Patients undergo open reduction and internal fixation of displaced intra-articular calcaneal fractures through an extended lateral approach. Fracture reduction is achieved under fluoroscopic guidance, restoring Bohler's and Gissane's angles. Fixation is performed using a locking calcaneal plate with screws. Postoperative care includes immobilization in a cast or splint, non-weight bearing for 8 weeks, followed by a standardized physiotherapy program. This procedure is distinguished from other calcaneal fracture treatments by the use of locking plate technology and precise anatomical reduction for Sanders type III and IV fractur Receives: Procedure: Open reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthopedic foot and ankle AOFAS
Measured: 2,4,6,8,12 weeks,6 months and 1.5years after operation
Orthopedic foot and ankle score (AOFAS)
Measured: 2'4'8'12 weeks' 6 months, and 1.5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion2 Jan 2028 (estimated)
- Study completion2 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneus FracturesStudies of the same condition, open and under way.
- 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
- Ahmed Gamal Ibrahim Saleh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Gamal Ibrahim Saleh, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423507
- Sponsor's protocol ID
- Calcaneal Fracture
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Internal Fixtion And Primary Subtalar Arthrodesis In Comminuted Intra-Articular Calcaneal Fracture
- ClinicalTrials.gov ID
- NCT07423507
- Acronym / sponsor ID
- Calcaneal Fracture
- Conditions
- Calcaneus Fractures
- Keywords
- primary subtalar arthrodesis VS ORIF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ahmed Gamal Ibrahim SalehUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 2 Jan 2028 (estimated)
- Study completion
- 2 Jan 2028 (estimated)
- First posted
- 20 Feb 2026 (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.
This study is to compare clinical outcome of Sanders type III or IV intra-articular calcaneal fracture treated with open reduction and internal fixation (ORIF) versus ORIF and primary subtalar arthrodesis (PSTA).
Detailed description
The calcaneal fractures are the most common tarsal bone fracture, accounting for up to 2% of all fractures in the human body, of which approximately 75% of these fractures are intra-articular.(Almeida, Vale et al. 2022) The calcaneal fractures are serious injuries, often resulting from traumatic axial loading as falls from height or motor vehicle accidents. clinically, it manifests as swelling, pain, ecchymosis, edema of the distal extremity, and an inability to bear weight. Sometimes, anatomical deformity of the hindfoot is noted.(Giuliani, Calori et al. 2025) Radiographic classification of calcaneal fractures is essential for guiding treatment. The Essex-Lopresti classification, one of the oldest reference systems, classifies fractures into tongue type and joint depression-type based on the fracture pattern and orientation of the fracture line. This classification remains important today, particularly for determining surgical approaches and predicting complications.(Essex-Lopresti 1952) Additionally, the Sanders system, currently one of the most widely utilized classification systems for calcaneal fractures, categorizes intra-articular fractures into four types (Type I, II, III, and IV) based on the number and location of fracture lines and fragments.(Sanders 2000, Galluzzo, Greco et al. 2018) Historically, comminuted intra-articular calcaneal fractures were treated nonoperatively, as predictable operative reduction and fixation were not possible. Presently, surgical treatment through ORIF is considered the standard management.(Buckley, Tough et al. 2010, Sanders, Vaupel et al. 2014) Although ORIF has improved clinical and radiological outcomes of comminuted intra-articular calcaneal fractures, Sanders and colleagues reported that fractures involving complications after surgery, proposing primary subtalar arthrodesis (PSA) as alternative.(Eisenstein, Kusnezov et al. 2018, Maccagnano, Noia et al. 2021) Several authors advocate PSA in cases of highly comminuted fractures due to favorable functional results, The management of these fracture patterns is not well established, and the literature remains controversial.(Cianni, Vitiello et al. 2022, Giuliani, Calori et al. 2025).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Subtalar Arthrodesis Group | Experimental | Procedure: Primary Subtalar ArthrodesisPatients with Sanders type III and IV intra-articular calcaneal fractures treated with primary subtalar arthrodesis using cannulated compression screws with plate fixation through an extended lateral approach. |
| Open Reduction and Internal Fixation | Experimental | Procedure: Open reduction and internal fixationPatients undergo open reduction and internal fixation of displaced intra-articular calcaneal fractures through an extended lateral approach. Fracture reduction is achieved under fluoroscopic guidance, restoring Bohler's and Gissane's angles. Fixation is performed using a locking calcaneal plate with screws. Postoperative care includes immobilization in a cast or splint, non-weight bearing for 8 weeks, followed by a standardized physiotherapy program. This procedure is distinguished from other calcaneal fracture treatments by the use of locking plate technology and precise anatomical reduction for Sanders type III and IV fractur |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sanders type 3 and 4 intra articular calcaneal fracture within 14 day of injury
Key exclusion criteria (1 listed)
- patient with open injury, concomitant foot injury, vascular compromise and prior subtalar pathology
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 |
|---|---|---|
| Primary Subtalar ArthrodesisPatients undergo primary subtalar arthrodesis via an extended lateral approach. The articular cartilage of the subtalar joint is removed, the calcaneal morphology is restored, and fixation is achieved using cannulated compression screws with a locking plate. Postoperative care follows the same protocol as the ORIF group. This intervention is distinguished from other surgical techniques by performing fusion as the primary treatment in severely comminuted Sanders type III and IV fractures, aiming to reduce the risk of post-traumatic subtalar arthritis. | Procedure or surgery | Primary Subtalar Arthrodesis Group |
| Open reduction and internal fixationPatients undergo open reduction and internal fixation of displaced intra-articular calcaneal fractures through an extended lateral approach. Fracture reduction is achieved under fluoroscopic guidance, restoring Bohler's and Gissane's angles. Fixation is performed using a locking calcaneal plate with screws. Postoperative care includes immobilization in a cast or splint, non-weight bearing for 8 weeks, followed by a standardized physiotherapy program. This procedure is distinguished from other calcaneal fracture treatments by the use of locking plate technology and precise anatomical reduction for Sanders type III and IV fractures | Procedure or surgery | Open Reduction and Internal Fixation |
Primary outcome
Orthopedic foot and ankle AOFAS
Time frame: 2,4,6,8,12 weeks,6 months and 1.5years after operation
Orthopedic foot and ankle score (AOFAS)
Time frame: 2'4'8'12 weeks' 6 months, and 1.5 years after surgery
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 20 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Subtalar Arthrodesis and Open reduction and internal fixation in people with Calcaneus Fractures, run by Ahmed Gamal Ibrahim Saleh.
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: opening soon, as of the sponsor's last update on 20 Feb 2026. 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?
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?
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?
Orthopedic foot and ankle AOFAS (time frame: 2,4,6,8,12 weeks,6 months and 1.5years after operation). The study lists 2 primary outcomes in all. 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 Feb 2026.