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

NCT07423507 | Not Yet Recruiting

• 1 other identifier: Calcaneal Fracture
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Calcaneus Fractures

Keywords

primary subtalar arthrodesis VS ORIF

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Primary Subtalar Arthrodesis Group

EXPERIMENTAL

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

Open Reduction and Internal Fixation

EXPERIMENTAL

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

Interventions

Primary Subtalar Arthrodesis PROCEDURE

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.

Primary Subtalar Arthrodesis Group

Open reduction and internal fixation PROCEDURE

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

Open Reduction and Internal Fixation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ahmed Gamal Ibrahim Saleh: lead

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: A Prospective Randomized Controlled Trial Comparing ORIF with Primary Subtalar Arthrodesis Versus Open Reduction and Internal Fixation in Sanders Type III and IV Intra-Articular Calcaneal Fractures

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2028
• Last Updated: February 20, 2026

Record last verified: 2025-03