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

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

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

Study Overview

• Status: Recruiting
• Conditions: Calcaneus Fracture
• Intervention / Treatment: Procedure: Sinus tarsi approach (STA); Procedure: Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wolfram Grün, MD; Phone Number: +4741297874; Email: wolframgruen@hotmail.com
• Study Contact Backup: Name: Marius Molund, MD, PhD; Phone Number: +4790093988; Email: mariusmolund@hotmail.com

Study Locations

• Norway
  • Bergen, Norway
    • Recruiting
    • Haukeland University Hospital
    • Contact: Gard Kristian Anderssen, MD; Email: gard.kristian.anderssen@helse-bergen.no
  • Drammen, Norway
    • Recruiting
    • Vestre Viken Hospital Trust - Drammen hospital
    • Contact: Erik Bjørbæk, MD; Email: B30957@vestreviken.no
  • Oslo, Norway, 0588
    • Recruiting
    • Oslo university hospial
    • Contact: Wolfram Grün, MD; Phone Number: +4741297874; Email: wolframgruen@hotmail.com
    • Contact: Are Stødle, MD; Phone Number: +4797174507; Email: arhauk@ous-hf.no
    • Sub-Investigator: Elisabeth Ellingsen Husebye, MD, PhD
  • Sandvika, Norway
    • Recruiting
    • Vestre Viken Hospital Trust - Bærum hospital
    • Contact: Espen Laudal, MD; Email: eslaud@vestreviken.no
  • Østfold
    • Sarpsborg, Østfold, Norway, 1714
      • Recruiting
      • Østfold Hospital Trust
      • Contact: Marius Molund, MD, PhD; Phone Number: +4790093988; Email: marius.molund@so-hf.no
      • Contact: Fredrik Nilsen, MD; Email: fredni@so-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sinus tarsi approach (STA); Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach	Procedure: Sinus tarsi approach (STA); Osteosynthesis
Active Comparator: 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	Procedure: Percutaneous Arthroscopically Assisted Osteosynthesis (PACO); Osteosynthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manchester-Oxford Foot Questionnaire (MOxFQ)	Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported foot and ankle score (SEFAS)	Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)	5 years
Visual Analogue Scale (VAS) for pain	Scores pain at rest and on activity (0-10 with 0 representing no pain)	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)	5 years
Calcaneus Fracture Scoring System (CFSS)	Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)	5 years
Incidence of complications	Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery	5 years
Böhler angle	Böhler angle pre- and post surgery as well as at follow up	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.	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.	5 years

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: Vestre Viken Hospital Trust; Oslo University Hospital; Haukeland University Hospital
• Investigators: Principal Investigator: Are Stødle, MD, Oslo University Hospital; Principal Investigator: Frede Frihagen, MD, PhD, Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 1, 2031

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Trauma; Calcaneus; Calcaneal fracture; Subtalar arthroscopy
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 20/00912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No