Clinical trial NCT04372251: Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach
Official title: Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Calcaneus Fracture
Keywords: Calcaneal fracture
Subtalar arthroscopy
Trauma
Calcaneus
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Haukeland University Hospital
name: Vestre Viken Hospital Trust
First posted: 2020-05-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel assignment. Patients er randomized to operative treatment with either the sinus tarsi approach or percutaneous and arthroscopically assisted osteosynthesis.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Manchester-Oxford Foot Questionnaire (MOxFQ)
timeFrame: 5 years
Secondary outcomes:
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score
timeFrame: 5 years
measure: Calcaneus Fracture Scoring System (CFSS)
timeFrame: 5 years
measure: Self-reported foot and ankle score (SEFAS)
timeFrame: 5 years
measure: Visual Analogue Scale (VAS) for pain
timeFrame: 5 years
measure: Incidence of complications
timeFrame: 5 years
measure: Böhler angle
timeFrame: 5 years
measure: Subtalar osteoarthritis
timeFrame: 5 years
measure: EQ-5D-5L
timeFrame: 5 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust - Drammen hospital
city: Oslo
country: Norway
facility: Oslo university hospial
city: Sandvika
country: Norway
facility: Vestre Viken Hospital Trust - Bærum hospital
city: Sarpsborg
country: Norway
facility: Østfold Hospital Trust
state: Østfold
Study officials:
affiliation: Oslo University Hospital
name: Are Stødle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ostfold Hospital Trust
name: Frede Frihagen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: