Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach

Calcaneus Fracture Clinical Trial

Official title:

Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04372251
• Other study ID #: 20/00912
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2020
• Est. completion date: December 2031

Study information

• Verified date: April 2022
• Source: Ostfold Hospital Trust
• Contact: Wolfram Grün, MD
• Phone: +4741297874
• Email: wolframgruen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.

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 information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2031
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcaneus Fracture
• Fractures, Bone

Intervention

Procedure:
• Sinus tarsi approach (STA)
Osteosynthesis
• Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
Osteosynthesis

Locations

Country	Name	City	State
Norway	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

Sponsors (4)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Haukeland University Hospital, Oslo University Hospital, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manchester-Oxford Foot Questionnaire (MOxFQ)	Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)	5 years
Secondary	American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score	Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)	5 years
Secondary	Calcaneus Fracture Scoring System (CFSS)	Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)	5 years
Secondary	Self-reported foot and ankle score (SEFAS)	Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)	5 years
Secondary	Visual Analogue Scale (VAS) for pain	Scores pain at rest and on activity (0-10 with 0 representing no pain)	5 years
Secondary	Incidence of complications	Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery	5 years
Secondary	Böhler angle	Böhler angle pre- and post surgery as well as at follow up	5 years
Secondary	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.	5 years
Secondary	EQ-5D-5L	Measure of health-related quality of life. This will be evaluated at the 2-year and 5 -year follow-up.	5 years