Calcaneus FractureNCT05504304
Primary Subtalar Arthrodesis Versus Late Subtalar Arthrodesis in Sanders Type IV Calcaneal Fractures
A study testing open reduction and internal fixation plus primary subtalar arthrodesis and conservative management then calcaneoplasty and subtalar arthrodesis. in people with Calcaneus Fracture, run by Ain Shams University at 1 site in Egypt.
Trial summary
Fracture calcaneus accounts for up to 2% of all fractures. 75% of calcaneal fractures are displaced intra-articular fractures and historically have been associated with poor functional outcomes. Read more about this study
- Who is it for?
- Ages 16 to 59 years
- Conditions the study is for
- Calcaneus Fracture
- What is being tested?
- open reduction and internal fixation plus primary subtalar arthrodesis and conservative management then calcaneoplasty and subtalar arthrodesis.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2019to 30 Oct 2022
- 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 16 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with a Sanders IV displaced intra-articular calcaneal fracture (DIACF).
- Within 12 months from injury.
- Clear demonstration of at least 3 fracture lines across the posterior subtalar facet, dividing it into at least 4 fragments and the fragments being displaced by at least 2 mm, as seen on the coronal and axial CT scans (classified as Sanders IV).
- Ability to provide informed consent.
- Available for follow-up for at least 6 months after intervention.
Who cannot join
- Medical contraindications to surgery.
- Fracture more than 12 months old at first presentation.
- Previous calcaneal pathology (infection, tumor etc).
- Previous calcaneal surgery.
- Co-existent foot or ipsilateral lower limb injury.
- Open calcaneal fractures.
- Inability to obtain preoperative CT scans or accurately classify the fractures as per Sanders classification system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Sanders Type IV Calcaneal Fractures Treated With Open Reduction and Internal Fixation (ORIF) Plus Primary Subtalar Arthrodesis (PSTA) Versus Conservative Management Then Calcaneoplasty and Late Subtalar Arthrodesis.
Fracture calcaneus accounts for up to 2% of all fractures. 75% of calcaneal fractures are displaced intra-articular fractures and historically have been associated with poor functional outcomes.
When the talus applies an axial loading to the posterior facet, shear forces result in a primary fracture line between medial (sustentaculum tali) and lateral part of the calcaneus. As the axial force continues, a secondary fracture line will develop. According to the relation of the secondary fracture line's exit to insertion of tendo-achilis Essex-Lopresti classified that into two types joint depression and tongue.
Read more
Numerous classifications exist in the literature but that by Sanders is the most prevalent and best suited for clinical practice and for research purposes.
Sanders in his clinical trials found that as the number of articular fragments- based on axial and coronal CT scan cuts with the widest undersurface of the posterior facet of the talus- increase, the results and prognosis worsen.
Up to 73% in the sanders type IV fractures eventually leads to subtalar fusion to manage post-traumatic subtalar arthritis. They are 5.5 times more likely to require subtalar arthrodesis than Sanders II fractures. Second surgeries increase the cost of management and delay the return of level of function for the patient.
Some authors advocate that the fractures with a higher Sanders classification demonstrated no difference between operative and non-operative treatment. However, careful stratification of the patients may show better outcomes after surgical intervention in some groups.
There is no consensus about how to manage calcaneal fractures but we can divide management into four broad categories: Non-operative, Open reduction and internal fixation, Minimally invasive reduction and fixation and finally Primary ORIF and subtalar arthrodesis.
Our trial was conducted to add to the current evidence and our main questions are: does initial reduction and fixation of comminuted displaced intra-articular Sanders type IV calcaneal fractures matter in subtalar fusion?
Read the detailed description
Randomization: patients presented to clinic or emergency room with recent (30 days or less) Sanders type IV intra-articular calcaneal fractures will be included in group A. Patients referred to our clinic (from other surgeons or hospitals) with old (more than three months) Sanders type IV intra-articular calcaneal fractures will form group B.
Group A: open reduction and internal fixation plus primary subtalar arthrodesis.
Group B: conservative management for at least three months then calcaneoplasty and late subtalar arthrodesis.
Ethical Considerations: Will be followed by obtaining the hospital Research Ethics Committee approval and written informed consents from the patients.
Intervention:
All patients were subjected to the same initial treatment with below knee slab, limb elevation and analgesics.
Patient in group A will be scheduled to surgery after resolution of the edema and appearance of wrinkle sign.
They will be anesthetized and tourniquet will be applied over the thigh. Lateral position and lateral extensile approach will be used. A full flap will be developed by subperiosteal dissection with protection of sural nerve and peroneal tendons. Three k-wires will be inserted in fibula, lateral surface of talus and cuboid bones as retractors.
A 4 mm schanz will be inserted in the calcaneal tuberosity from lateral side to control varus and to restore calcaneal height. Lateral wall of the calcaneus will be lifted keeping it attached inferiorly. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. tricortical iliac bone autograft will be inserted the subtalar joint. A lateral nonlocked plate will be applied to reduce the lateral wall blow out and broadening then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks.
Group B patients will be assessed upon 1st clinic visit. After at least three months patients will be scheduled for subtalar arthrodesis. A new preoperative ankle CT scan will be done.
Patients will be anesthetized and tourniquet will be applied over the thigh. Lateral position and lateral extensile approach will be used. A full flap will be developed by subperiosteal dissection with protection of sural nerve and peroneal tendons. Three k-wires will be inserted in fibula, lateral surface of talus and cuboid bones as retractors.
Lateral wall and plantar exostosis will be resected. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. Hind foot deformity (mostly varus) will be corrected through the subtalar joint manually and checked clinically. Loss of calcaneal height will be corrected by tricortical iliac bone autograft to distract the subtalar joint then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks.
Post operatively, both groups will be followed after intervention every two weeks for two months then every three months for one year. Outcomes will be assessed using questionnaires in our clinic at six months and one-year visits.
- Conditions
- Calcaneus Fracture
- Being tested
- open reduction and internal fixation plus primary subtalar arthrodesis, conservative management then calcaneoplasty and subtalar arthrodesis.
- Keywords
- Primary subtalar arthrodesis, Late subtalar fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reduction and internal fixation plus primary subtalar arthrodesisProcedure or surgery
they will be scheduled to surgery after resolution of the edema and appearance of wrinkle sign. Lateral position and lateral extensile approach will be used. A 4 mm schanz will be inserted in the calcaneal tuberosity from lateral side to control varus and to restore calcaneal height. Lateral wall of the calcaneus will be lifted keeping it attached inferiorly. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. tricortical iliac bone autograft will be inserted the subtalar joint. A lateral nonlocked plate will be applied to reduce the lateral wall blow out and broadening then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks.
conservative management then calcaneoplasty and subtalar arthrodesis.Procedure or surgery
they will be assessed upon 1st clinic visit. After at least three months patients will be scheduled for subtalar arthrodesis. A new preoperative ankle CT scan will be done. Lateral position and lateral extensile approach will be used. Lateral wall and plantar exostosis will be resected. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. Hind foot deformity (mostly varus) will be corrected through the subtalar joint manually and checked clinically. Loss of calcaneal height will be corrected by tricortical iliac bone autograft to distract the subtalar joint then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A: open reduction and internal fixation plus primary subtalar arthrodesis. | Active comparator | they will be scheduled to surgery after resolution of the edema and appearance of wrinkle sign. Lateral position and lateral extensile approach will be used. A 4 mm schanz will be inserted in the calcaneal tuberosity from lateral side to control varus and to restore calcaneal height. Lateral wall of the calcaneus will be lifted keeping it attached inferiorly. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. tricortical iliac bone autograft will be inserted the subtalar joint. A lateral nonlocked plate will be applied to reduce the lateral wall blow out and broadening then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks. Receives: Procedure: open reduction and internal fixation plus primary subtalar arthrodesis |
| Group B: conservative management then calcaneoplasty and subtalar arthrodesis. | Active comparator | they will be assessed upon 1st clinic visit. After at least three months patients will be scheduled for subtalar arthrodesis. A new preoperative ankle CT scan will be done. Lateral position and lateral extensile approach will be used. Lateral wall and plantar exostosis will be resected. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. Hind foot deformity (mostly varus) will be corrected through the subtalar joint manually and checked clinically. Loss of calcaneal height will be corrected by tricortical iliac bone autograft to distract the subtalar joint then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks. Receives: Procedure: conservative management then calcaneoplasty and subtalar arthrodesis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the American Orthopaedic Foot and Ankle Society's Ankle-Hindfoot score (AOFAS score)
functional state of the patient
Measured: up to two years
Foot and Ankle Ability Measure (FAAM).
functional state of the patient
Measured: up to two years
time to return to work in months
the time from injury till resuming their jobs (if returned to job)
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start30 Sep 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneus FractureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bishoy Emil, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504304
- Sponsor's protocol ID
- MD
- Status last verified
- Feb 2023
- First submitted
- 31 Jul 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: if needed will be shared as excel sheets
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Sanders Type IV Calcaneal Fractures Treated With Open Reduction and Internal Fixation (ORIF) Plus Primary Subtalar Arthrodesis (PSTA) Versus Conservative Management Then Calcaneoplasty and Late Subtalar Arthrodesis.
- ClinicalTrials.gov ID
- NCT05504304
- Acronym / sponsor ID
- MD
- Conditions
- Calcaneus Fracture
- Keywords
- Primary subtalar arthrodesis, Late subtalar fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 17 Aug 2022 (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.
Fracture calcaneus accounts for up to 2% of all fractures. 75% of calcaneal fractures are displaced intra-articular fractures and historically have been associated with poor functional outcomes.
When the talus applies an axial loading to the posterior facet, shear forces result in a primary fracture line between medial (sustentaculum tali) and lateral part of the calcaneus. As the axial force continues, a secondary fracture line will develop. According to the relation of the secondary fracture line's exit to insertion of tendo-achilis Essex-Lopresti classified that into two types joint depression and tongue.
Numerous classifications exist in the literature but that by Sanders is the most prevalent and best suited for clinical practice and for research purposes.
Sanders in his clinical trials found that as the number of articular fragments- based on axial and coronal CT scan cuts with the widest undersurface of the posterior facet of the talus- increase, the results and prognosis worsen.
Up to 73% in the sanders type IV fractures eventually leads to subtalar fusion to manage post-traumatic subtalar arthritis. They are 5.5 times more likely to require subtalar arthrodesis than Sanders II fractures. Second surgeries increase the cost of management and delay the return of level of function for the patient.
Some authors advocate that the fractures with a higher Sanders classification demonstrated no difference between operative and non-operative treatment. However, careful stratification of the patients may show better outcomes after surgical intervention in some groups.
There is no consensus about how to manage calcaneal fractures but we can divide management into four broad categories: Non-operative, Open reduction and internal fixation, Minimally invasive reduction and fixation and finally Primary ORIF and subtalar arthrodesis.
Our trial was conducted to add to the current evidence and our main questions are: does initial reduction and fixation of comminuted displaced intra-articular Sanders type IV calcaneal fractures matter in subtalar fusion?
Detailed description
Randomization: patients presented to clinic or emergency room with recent (30 days or less) Sanders type IV intra-articular calcaneal fractures will be included in group A. Patients referred to our clinic (from other surgeons or hospitals) with old (more than three months) Sanders type IV intra-articular calcaneal fractures will form group B.
Group A: open reduction and internal fixation plus primary subtalar arthrodesis.
Group B: conservative management for at least three months then calcaneoplasty and late subtalar arthrodesis.
Ethical Considerations: Will be followed by obtaining the hospital Research Ethics Committee approval and written informed consents from the patients.
Intervention:
All patients were subjected to the same initial treatment with below knee slab, limb elevation and analgesics.
Patient in group A will be scheduled to surgery after resolution of the edema and appearance of wrinkle sign.
They will be anesthetized and tourniquet will be applied over the thigh. Lateral position and lateral extensile approach will be used. A full flap will be developed by subperiosteal dissection with protection of sural nerve and peroneal tendons. Three k-wires will be inserted in fibula, lateral surface of talus and cuboid bones as retractors.
A 4 mm schanz will be inserted in the calcaneal tuberosity from lateral side to control varus and to restore calcaneal height. Lateral wall of the calcaneus will be lifted keeping it attached inferiorly. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. tricortical iliac bone autograft will be inserted the subtalar joint. A lateral nonlocked plate will be applied to reduce the lateral wall blow out and broadening then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks.
Group B patients will be assessed upon 1st clinic visit. After at least three months patients will be scheduled for subtalar arthrodesis. A new preoperative ankle CT scan will be done.
Patients will be anesthetized and tourniquet will be applied over the thigh. Lateral position and lateral extensile approach will be used. A full flap will be developed by subperiosteal dissection with protection of sural nerve and peroneal tendons. Three k-wires will be inserted in fibula, lateral surface of talus and cuboid bones as retractors.
Lateral wall and plantar exostosis will be resected. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. Hind foot deformity (mostly varus) will be corrected through the subtalar joint manually and checked clinically. Loss of calcaneal height will be corrected by tricortical iliac bone autograft to distract the subtalar joint then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks.
Post operatively, both groups will be followed after intervention every two weeks for two months then every three months for one year. Outcomes will be assessed using questionnaires in our clinic at six months and one-year visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: open reduction and internal fixation plus primary subtalar arthrodesis. | Active comparator | Procedure: open reduction and internal fixation plus primary subtalar arthrodesisthey will be scheduled to surgery after resolution of the edema and appearance of wrinkle sign. Lateral position and lateral extensile approach will be used. A 4 mm schanz will be inserted in the calcaneal tuberosity from lateral side to control varus and to restore calcaneal height. Lateral wall of the calcaneus will be lifted keeping it attached inferiorly. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. tricortical iliac bone autograft will be inserted the subtalar joint. A lateral nonlocked plate will be applied to reduce the lateral wall blow out and broadening then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks. |
| Group B: conservative management then calcaneoplasty and subtalar arthrodesis. | Active comparator | Procedure: conservative management then calcaneoplasty and subtalar arthrodesis.they will be assessed upon 1st clinic visit. After at least three months patients will be scheduled for subtalar arthrodesis. A new preoperative ankle CT scan will be done. Lateral position and lateral extensile approach will be used. Lateral wall and plantar exostosis will be resected. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. Hind foot deformity (mostly varus) will be corrected through the subtalar joint manually and checked clinically. Loss of calcaneal height will be corrected by tricortical iliac bone autograft to distract the subtalar joint then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks. |
Who may qualify
- Ages
- 16 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with a Sanders IV displaced intra-articular calcaneal fracture (DIACF).
- Within 12 months from injury.
- Clear demonstration of at least 3 fracture lines across the posterior subtalar facet, dividing it into at least 4 fragments and the fragments being displaced by at least 2 mm, as seen on the coronal and axial CT scans (classified as Sanders IV).
- Ability to provide informed consent.
- Available for follow-up for at least 6 months after intervention.
Key exclusion criteria (7 listed)
- Medical contraindications to surgery.
- Fracture more than 12 months old at first presentation.
- Previous calcaneal pathology (infection, tumor etc).
- Previous calcaneal surgery.
- Co-existent foot or ipsilateral lower limb injury.
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 |
|---|---|---|
| open reduction and internal fixation plus primary subtalar arthrodesisthey will be scheduled to surgery after resolution of the edema and appearance of wrinkle sign. Lateral position and lateral extensile approach will be used. A 4 mm schanz will be inserted in the calcaneal tuberosity from lateral side to control varus and to restore calcaneal height. Lateral wall of the calcaneus will be lifted keeping it attached inferiorly. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. tricortical iliac bone autograft will be inserted the subtalar joint. A lateral nonlocked plate will be applied to reduce the lateral wall blow out and broadening then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks. | Procedure or surgery | Group A: open reduction and internal fixation plus primary subtalar arthrodesis. |
| conservative management then calcaneoplasty and subtalar arthrodesis.they will be assessed upon 1st clinic visit. After at least three months patients will be scheduled for subtalar arthrodesis. A new preoperative ankle CT scan will be done. Lateral position and lateral extensile approach will be used. Lateral wall and plantar exostosis will be resected. Articular surfaces of inferior surface of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. Hind foot deformity (mostly varus) will be corrected through the subtalar joint manually and checked clinically. Loss of calcaneal height will be corrected by tricortical iliac bone autograft to distract the subtalar joint then fixation by two cannulated partially threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee slab will be applied and non-weight bearing for six weeks. | Procedure or surgery | Group B: conservative management then calcaneoplasty and subtalar arthrodesis. |
Primary outcome
the American Orthopaedic Foot and Ankle Society's Ankle-Hindfoot score (AOFAS score)
Time frame: up to two years
functional state of the patient
Foot and Ankle Ability Measure (FAAM).
Time frame: up to two years
functional state of the patient
time to return to work in months
Time frame: up to two years
the time from injury till resuming their jobs (if returned to job)
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 9 Feb 2023.
- Individual participant dataSharing planned: Yes. if needed will be shared as excel sheets
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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. 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?
A study testing open reduction and internal fixation plus primary subtalar arthrodesis and conservative management then calcaneoplasty and subtalar arthrodesis. in people with Calcaneus Fracture, run by Ain Shams 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 5 inclusion and 7 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 9 Feb 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?
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?
the American Orthopaedic Foot and Ankle Society's Ankle-Hindfoot score (AOFAS score) (time frame: up to two years). The study lists 3 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 9 Feb 2023.