Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach
NCT ID: NCT04372251
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
70 participants
INTERVENTIONAL
2020-05-05
2031-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sinus tarsi approach (STA)
Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach
Sinus tarsi approach (STA)
Osteosynthesis
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
Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
Osteosynthesis
Interventions
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Sinus tarsi approach (STA)
Osteosynthesis
Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
Osteosynthesis
Eligibility Criteria
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Inclusion Criteria
* Patients between 18 and 70 years of age
* Acute presentation at one of our departments, enabling surgery within 10 days after injury
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Haukeland University Hospital
OTHER
Vestre Viken Hospital Trust
OTHER
Ostfold Hospital Trust
OTHER
Responsible Party
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Principal Investigators
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Are Stødle, MD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Frede Frihagen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ostfold Hospital Trust
Locations
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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 fylke, Norway
Countries
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Other Identifiers
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20/00912
Identifier Type: -
Identifier Source: org_study_id