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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2031
  • participants needed
    70
  • sponsor
    Ostfold Hospital Trust
Updated on 19 February 2024

Summary

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

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 non-inferiority study. Our hypothesis is that the percutaneous and arthroscopically assisted technique provides non-inferior outcomes compared to the sinus tarsi approach in Sanders II and III calcaneal fractures.

Details
Condition Calcaneus Fracture
Age 18years - 70years
Treatment Sinus tarsi approach (STA), Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
Clinical Study IdentifierNCT04372251
SponsorOstfold Hospital Trust
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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