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

NCT04372251 | Active Not Recruiting

• 1 other identifier: 20/00912
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Calcaneus Fracture

Keywords

Calcaneal fracture; Subtalar arthroscopy; Trauma; Calcaneus

Outcome Measures

Primary Outcomes (1)

• Manchester-Oxford Foot Questionnaire (MOxFQ)

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

  5 years

Secondary Outcomes (8)

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

  5 years

• Calcaneus Fracture Scoring System (CFSS)

  5 years

• Self-reported foot and ankle score (SEFAS)

  5 years

• Visual Analogue Scale (VAS) for pain

  5 years

• Incidence of complications

  5 years

Study Arms (2)

Sinus tarsi approach (STA)

ACTIVE COMPARATOR

Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach

Procedure: Sinus tarsi approach (STA)

Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)

ACTIVE COMPARATOR

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)

Interventions

Sinus tarsi approach (STA) PROCEDURE

Osteosynthesis

Sinus tarsi approach (STA)

Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) PROCEDURE

Osteosynthesis

Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Oslo University Hospital: collaborator
• Haukeland University Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator

Study Sites (5)

Haukeland University Hospital

Bergen, Norway

Location

Vestre Viken Hospital Trust - Drammen hospital

Drammen, Norway

Location

Oslo university hospial

Oslo, 0588, Norway

Location

Vestre Viken Hospital Trust - Bærum hospital

Sandvika, Norway

Location

Østfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Are Stødle, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Frede Frihagen, MD, PhD

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators that will conduct the follow-up examinations 2 and 5 years after surgery will be blinded for the operative treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm parallel assignment. Patients er randomized to operative treatment with either the sinus tarsi approach or percutaneous and arthroscopically assisted osteosynthesis.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: May 5, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)