Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach

Ostfold Hospital Trust

Status: Active, not recruiting

Conditions: Calcaneus Fracture

Treatments: Procedure: Percutaneous Arthroscopically Assisted Osteosynthesis (PACO); Procedure: Sinus tarsi approach (STA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04372251

20/00912

Details and patient eligibility

About

In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.

Full description

Operative treatment of calcaneal features through an extensile lateral approach (ELA) has been the gold standard over many years despite high rates of infection and soft tissue complications.

Lately, there has been a trend towards less invasive fixation methods. Minimally invasive plate osteosynthesis using the sinus tarsi approach (STA) has gained popularity during the last decade.

Furthermore, percutaneous reduction and fixation techniques have been described and used for a few decades. In the early 2000s, Rammelt et al. were the first who introduced a percutaneous technique assisted by hindfoot arthroscopy. The percutaneous and arthroscopically assisted calcaneal osteosynthesis (PACO) is applicable in Sanders II and III fractures and has been shown to provide good clinical outcomes as well as a low rate of complications.

The study is designed as a superiority study. Our hypothesis is that the percutaneous and arthroscopically assisted technique provides superior outcomes compared to the sinus tarsi approach in Sanders II and III calcaneal fractures.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dislocated intraarticular calcaneal fracture, type Sanders II or Sanders III with an intraarticular step > 2mm
• Patients between 18 and 70 years of age
• Acute presentation at one of our departments, enabling surgery within 10 days after injury

Exclusion criteria

• Intraarticular step of < 2mm
• Sanders IV fractures
• Open fractures
• Bilateral injuries
• Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process
• Multitraumized patients
• Previous injury or surgery of the hindfoot
• Charcot foot
• Serious medical condition that contradicts surgery
• Noncompliant patients
• Insufficient Norwegian or English language skills
• Patients not available for follow-up
• Inability to conduct the rehabilitation protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Sinus tarsi approach (STA)

Active Comparator group

Description:

Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach

Treatment:

Procedure: Sinus tarsi approach (STA)

Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)

Active Comparator group

Description:

Patients randomized to this arm are operated with percutaneous reduction of the fracture and osteosynthesis with screws, assisted by subtalar arthroscopy

Treatment:

Procedure: Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)