Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-29 @ 8:29 AM
Study NCT ID:
NCT04509895
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Minimally Invasive Calcaneal Fixation Via Sinus Tarsi Approach Vs Standard Lateral Extensile Approach in Calcaneal Fracture ( Randomized Controlled Trial )
Status:
COMPLETED
Status Verified Date:
2024-04
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:
a comparison between the standard lateral extensile approach and minimally invasive sinus tarsi approach in this research.
Detailed Description:
Calcaneal fracture occurred in about 2% of patients; they represented almost 60% of all tarsal fractures.
Calcaneal fractures are caused by high velocity Force to the heel, mostly vehicle accident or fall from height. There are many factors affect the fracture pattern: age of the patient, weight , type of fall . Male patients predominated (75%) and younger than 50 years. In most cases, these fractures are bilateral and conjoined with lumbar spine fractures.
According to the result of computed tomography (CT) scanning. The calcaneal fractures can be classified into 4 categories, among which the SANDERS TYPE Ⅱ and Ⅲ fractures are the most common types.2 Thus the development of effective and safe treatment strategies for these two fracture types has always been an issue among orthopedic surgeons.
The treatment of intra-articular calcaneal fractures has always been controversial. Currently open reduction and internal fixation through L-Shape extensile incision has been considered as the gold standard surgical therapy for calcaneal fractures. This approach provide a large view to expose the fracture, allowing accurate reduction of the deformed posterior facet and convenient placement of the plate to achieve stable fixation. Postoperatively, plaster cast is worn for 2 weeks, walking with the crutches for additional 8-12 weeks is prescribed, and return to work is achieved after 6-9 months. However, the high incidence (approximately 30%) of complications associated with this approach, including wound dehiscence and deep infection , remain a non-negligible problem .
To lower the wound complications , a minimally invasive approaches has been introduced such as percutaneously applied distraction systems K-wires or screw fixation of intra-articular fractures , the use of elizarov device , percutaneous arthroscopy assisted osteosynthesis and Sinus Tarsi approaches . The sinus tarsi approach has become one of the most frequently applied minimally invasive approaches because of its ability to provide adequate exposure for the posterior facet, the anterolateral fragment and the lateral wall. Wound complication rate with this approach have been reported to range from 0% to 15.4% . Nevertheless, the poor visualization of the lateral wall of the calcaneus through this small incision makes it difficult to insert the conventional plate for obtaining a stable fixation. Thus, the development of a plate that is adaptable to the anatomic characteristics of the calcaneus and sinus tarsi approach is important.
Calcaneal fractures are caused by high velocity Force to the heel, mostly vehicle accident or fall from height. There are many factors affect the fracture pattern: age of the patient, weight , type of fall . Male patients predominated (75%) and younger than 50 years. In most cases, these fractures are bilateral and conjoined with lumbar spine fractures.
According to the result of computed tomography (CT) scanning. The calcaneal fractures can be classified into 4 categories, among which the SANDERS TYPE Ⅱ and Ⅲ fractures are the most common types.2 Thus the development of effective and safe treatment strategies for these two fracture types has always been an issue among orthopedic surgeons.
The treatment of intra-articular calcaneal fractures has always been controversial. Currently open reduction and internal fixation through L-Shape extensile incision has been considered as the gold standard surgical therapy for calcaneal fractures. This approach provide a large view to expose the fracture, allowing accurate reduction of the deformed posterior facet and convenient placement of the plate to achieve stable fixation. Postoperatively, plaster cast is worn for 2 weeks, walking with the crutches for additional 8-12 weeks is prescribed, and return to work is achieved after 6-9 months. However, the high incidence (approximately 30%) of complications associated with this approach, including wound dehiscence and deep infection , remain a non-negligible problem .
To lower the wound complications , a minimally invasive approaches has been introduced such as percutaneously applied distraction systems K-wires or screw fixation of intra-articular fractures , the use of elizarov device , percutaneous arthroscopy assisted osteosynthesis and Sinus Tarsi approaches . The sinus tarsi approach has become one of the most frequently applied minimally invasive approaches because of its ability to provide adequate exposure for the posterior facet, the anterolateral fragment and the lateral wall. Wound complication rate with this approach have been reported to range from 0% to 15.4% . Nevertheless, the poor visualization of the lateral wall of the calcaneus through this small incision makes it difficult to insert the conventional plate for obtaining a stable fixation. Thus, the development of a plate that is adaptable to the anatomic characteristics of the calcaneus and sinus tarsi approach is important.
Study Oversight
Has Oversight DMC:
None
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?: