NCT07423507

Comparative Study Between Internal Fixtion And Primary Subtalar Arthrodesis In Comminuted Intra-Articular Calcaneal Fracture

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ahmed Gamal Ibrahim Saleh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
PROCEDURE	Primary Subtalar Arthrodesis	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.
PROCEDURE	Open reduction and internal fixation	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

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-01-02
• Completion: 2028-01-02
• First posted: 2026-02-20
• Last updated: 2026-02-20