Sinus tarsi approach (STA)
ProcedureOsteosynthesis
NCT Number: NCT04372251
In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.
This study is active but is not currently recruiting participants.
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Østfold Hospital Trust, Sarpsborg, Østfold fylke, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Osteosynthesis
Osteosynthesis
Time frame: 5 years
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
Time frame: 5 years
Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)
Time frame: 5 years
Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)
Time frame: 5 years
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Time frame: 5 years
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Time frame: 5 years
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 pre- and post surgery as well as at follow up
Time frame: 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.
Time frame: 5 years
Measure of health-related quality of life. This will be evaluated at the 2-year and 5 -year follow-up.
Ostfold Hospital Trust
Other
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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