Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04372251

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Østfold Hospital Trust, Sarpsborg, Østfold fylke, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinus tarsi approach (STA)

Procedure

Osteosynthesis

Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)

Procedure

Osteosynthesis

Primary outcomes

  1. Manchester-Oxford Foot Questionnaire (MOxFQ)

    Time frame: 5 years

    Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)

Secondary outcomes

  1. American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score

    Time frame: 5 years

    Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)

  2. Calcaneus Fracture Scoring System (CFSS)

    Time frame: 5 years

    Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)

  3. Self-reported foot and ankle score (SEFAS)

    Time frame: 5 years

    Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)

  4. Visual Analogue Scale (VAS) for pain

    Time frame: 5 years

    Scores pain at rest and on activity (0-10 with 0 representing no pain)

  5. Incidence of complications

    Time frame: 5 years

    Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery

  6. Böhler angle

    Time frame: 5 years

    Böhler angle pre- and post surgery as well as at follow up

  7. Subtalar osteoarthritis

    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.

  8. EQ-5D-5L

    Time frame: 5 years

    Measure of health-related quality of life. This will be evaluated at the 2-year and 5 -year follow-up.

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • Haukeland University Hospital
  • Oslo University Hospital
  • Vestre Viken Hospital Trust

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2030
Study completion
2031
First posted
May 4, 2020
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.