Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT04372251
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2020-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach
Sponsor:
Ostfold Hospital Trust
Organization:
Study Overview
Official Title:
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: