In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Osteosynthesis
Osteosynthesis
Haukeland University Hospital
Bergen, Norway
Vestre Viken Hospital Trust - Drammen hospital
Drammen, Norway
Oslo university hospial
Oslo, Norway
Vestre Viken Hospital Trust - Bærum hospital
Sandvika, Norway
Manchester-Oxford Foot Questionnaire (MOxFQ)
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
Time frame: 5 years
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score
Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)
Time frame: 5 years
Calcaneus Fracture Scoring System (CFSS)
Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)
Time frame: 5 years
Self-reported foot and ankle score (SEFAS)
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Time frame: 5 years
Visual Analogue Scale (VAS) for pain
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Time frame: 5 years
Incidence of complications
Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery
Time frame: 5 years
Böhler angle
Böhler angle pre- and post surgery as well as at follow up
Time frame: 5 years
Subtalar osteoarthritis
The presence of subtalar osteoarthritis is graded based CT scans taken at the 2 year and 5 year follow-up using the Kellgren \& Lawrence classification system.
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Østfold Hospital Trust
Sarpsborg, Østfold fylke, Norway
Time frame: 5 years
EQ-5D-5L
Measure of health-related quality of life. This will be evaluated at the 2-year and 5 -year follow-up.
Time frame: 5 years