Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach
- Conditions
- Calcaneus Fracture
- Interventions
- Procedure: Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)Procedure: Sinus tarsi approach (STA)
- Registration Number
- NCT04372251
- Lead Sponsor
- Ostfold Hospital Trust
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) Patients randomized to this arm are operated with percutaneous reduction of the fracture and osteosynthesis with screws, assisted by subtalar arthroscopy Sinus tarsi approach (STA) Sinus tarsi approach (STA) Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach
- Primary Outcome Measures
Name Time Method Manchester-Oxford Foot Questionnaire (MOxFQ) 5 years Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (5)
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
Østfold Hospital Trust
🇳🇴Sarpsborg, Østfold, Norway