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Primary Subtalar Arthrodesis Versus Late Subtalar Arthrodesis in Sanders Type IV Calcaneal Fractures

Primary Purpose

Calcaneus Fracture

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
open reduction and internal fixation plus primary subtalar arthrodesis
conservative management then calcaneoplasty and subtalar arthrodesis.
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcaneus Fracture focused on measuring Primary subtalar arthrodesis, Late subtalar fusion

Eligibility Criteria

16 Years - 59 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ain shams university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: open reduction and internal fixation plus primary subtalar arthrodesis.

Group B: conservative management then calcaneoplasty and subtalar arthrodesis.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the American Orthopaedic Foot and Ankle Society's Ankle-Hindfoot score (AOFAS score)
functional state of the patient
Foot and Ankle Ability Measure (FAAM).
functional state of the patient
time to return to work in months
the time from injury till resuming their jobs (if returned to job)

Secondary Outcome Measures

Full Information

First Posted
July 31, 2022
Last Updated
February 7, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05504304
Brief Title
Primary Subtalar Arthrodesis Versus Late Subtalar Arthrodesis in Sanders Type IV Calcaneal Fractures
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneus Fracture
Keywords
Primary subtalar arthrodesis, Late subtalar fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: open reduction and internal fixation plus primary subtalar arthrodesis.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B: conservative management then calcaneoplasty and subtalar arthrodesis.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
open reduction and internal fixation plus primary subtalar arthrodesis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conservative management then calcaneoplasty and subtalar arthrodesis.
Intervention Description
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.
Primary Outcome Measure Information:
Title
the American Orthopaedic Foot and Ankle Society's Ankle-Hindfoot score (AOFAS score)
Description
functional state of the patient
Time Frame
up to two years
Title
Foot and Ankle Ability Measure (FAAM).
Description
functional state of the patient
Time Frame
up to two years
Title
time to return to work in months
Description
the time from injury till resuming their jobs (if returned to job)
Time Frame
up to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Ain shams university hospital
City
Cairo
ZIP/Postal Code
1181
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
if needed will be shared as excel sheets
IPD Sharing Time Frame
after publication
IPD Sharing Access Criteria
open access

Learn more about this trial

Primary Subtalar Arthrodesis Versus Late Subtalar Arthrodesis in Sanders Type IV Calcaneal Fractures

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