Calcaneus Fracture
Conditions
Keywords
Calcaneal fracture, Subtalar arthroscopy, Trauma, Calcaneus
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.
Interventions
PROCEDURESinus tarsi approach (STA)
Osteosynthesis
PROCEDUREPercutaneous Arthroscopically Assisted Osteosynthesis (PACO)
Osteosynthesis
Sponsors
Oslo University Hospital
Haukeland University Hospital
Vestre Viken Hospital Trust
Ostfold Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The investigators that will conduct the follow-up examinations 2 and 5 years after surgery will be blinded for the operative treatment.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Manchester-Oxford Foot Questionnaire (MOxFQ) | 5 years | Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score | 5 years | Widely used foot/ankle score (0-100 with 100 representing the best possible outcome) |
| Calcaneus Fracture Scoring System (CFSS) | 5 years | Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome) |
| Self-reported foot and ankle score (SEFAS) | 5 years | Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome) |
| Visual Analogue Scale (VAS) for pain | 5 years | Scores pain at rest and on activity (0-10 with 0 representing no pain) |
| Incidence of complications | 5 years | Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery |
| Böhler angle | 5 years | Böhler angle pre- and post surgery as well as at follow up |
| Subtalar osteoarthritis | 5 years | 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. |
| EQ-5D-5L | 5 years | Measure of health-related quality of life. This will be evaluated at the 2-year and 5 -year follow-up. |
Countries
Norway
Outcome results
None listed