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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Calcaneus Fractures
• Intervention / Treatment: Procedure: Primary Subtalar Arthrodesis; Procedure: Open reduction and internal fixation

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).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sanders type 3 and 4 intra articular calcaneal fracture within 14 day of injury

Exclusion Criteria:

• patient with open injury, concomitant foot injury, vascular compromise and prior subtalar pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Subtalar Arthrodesis Group; Patients with Sanders type III and IV intra-articular calcaneal fractures treated with primary subtalar arthrodesis using cannulated compression screws with plate fixation through an extended lateral approach.	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.
Experimental: 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 fractur	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Orthopedic foot and ankle AOFAS	2,4,6,8,12 weeks,6 months and 1.5years after operation
Orthopedic foot and ankle score (AOFAS)	2'4'8'12 weeks' 6 months, and 1.5 years after surgery

Collaborators and Investigators

• Sponsor: Ahmed Gamal Ibrahim Saleh

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2028

Study Registration Dates

• First Submitted: February 14, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: primary subtalar arthrodesis VS ORIF
• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Orthopedic Procedures; Fracture Fixation; Open Fracture Reduction; Fracture Fixation, Internal
• Other Study ID Numbers: Calcaneal Fracture

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No