An interventional study of Sinus tarsi approach (STA) and Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) in Calcaneus Fracture, sponsored by Ostfold Hospital Trust. Active, not recruiting at 5 sites in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Ostfold Hospital Trust · Not applicable, Interventional, and Treatment
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.
5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.
This study's planned enrollment of 70 is above the median of 52 across 3,261 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Ostfold Hospital Trust is the lead sponsor of 50 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach
Procedure: Sinus tarsi approach (STA)
Patients randomized to this arm are operated with percutaneous reduction of the fracture and osteosynthesis with screws, assisted by subtalar arthroscopy
Procedure: Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
Osteosynthesis
Osteosynthesis
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.
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
Plan to share: No
No publications or documents are linked to this record.
Started May 2020 (actual). Primary completion is estimated for Dec 2030, 127 months after the start.
Of 1,289 non-industry interventional studies with no phase under Wounds and Injuries, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's planned 127 months is above that.
Counting every sponsor, half of 1,394 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Ostfold Hospital Trust