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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.
Sponsor study identifier
interventional
34
1 country
1
Study Start
September 30, 2019
Actual (reported)Primary Completion
October 30, 2020
Actual (reported)Study Completion
October 30, 2022
Actual (reported)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?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2019
Actual (reported)October 30, 2020
Actual (reported)July 31, 2022
Actual (reported)August 17, 2022
Actual (reported)October 30, 2022
Actual (reported)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
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.
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.
Ain shams university hospital
Cairo, 1181, Egypt
34 participants (actual enrollment reported by the registry).
First Submitted
July 31, 2022
First Posted
August 17, 2022
Study Start
September 30, 2019
Actual (reported)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.
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Primary Completion
October 30, 2020
Actual (reported)Study Completion
October 30, 2022
Actual (reported)Last Updated
February 9, 2023
Record last verified: 2023-02
if needed will be shared as excel sheets
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