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

NCT05504304 | Completed DMC

• 1 other identifier: MD
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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?

Conditions

Calcaneus Fracture

Keywords

Primary subtalar arthrodesis; Late subtalar fusion

Outcome Measures

Primary Outcomes (3)

• the American Orthopaedic Foot and Ankle Society's Ankle-Hindfoot score (AOFAS score)

  functional state of the patient

  up to two years

• Foot and Ankle Ability Measure (FAAM).

  functional state of the patient

  up to two years

• time to return to work in months

  the time from injury till resuming their jobs (if returned to job)

  up to two years

Study Arms (2)

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.

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.

Procedure: conservative management then calcaneoplasty and subtalar arthrodesis.

Interventions

open reduction and internal fixation plus primary subtalar arthrodesis PROCEDURE

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.

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

conservative management then calcaneoplasty and subtalar arthrodesis. PROCEDURE

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.

Group B: conservative management then calcaneoplasty and subtalar arthrodesis.

Eligibility Criteria

• Age: 16 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospital

Cairo, 1181, Egypt

Location

MeSH Terms

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 17, 2022
• Study Start: September 30, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication
• Access Criteria: open access

Locations

EG (1)