Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05799807
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-03-23
Brief Title:
Weight-bearing Diagnostics in Acute Lisfranc Injury CT vs X-ray
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Weight-bearing Diagnostics in Acute Lisfranc Injury A Prospective Study Comparing Computed Tomography Versus Conventional Radiography
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 prospective cohort study comparing weight-bearing computed tomography with weight-bearing radiography in patients with an acute Lisfranc injury
Detailed Description:
Injury to the tarsometatarsal TMT joint complex in the midfoot is referred to as a Lisfranc injury The broad spectrum of these injuries includes simple sprains to severe fracture-dislocations Variable clinical presentations and radiographic findings make Lisfranc injuries notoriously difficult to detect especially in the case of subtle ligament injuries Nowadays up to 30 of unstable Lisfranc injuries are overlooked or misdiagnosed This can potentially lead to severe sequelae such as post-traumatic osteoarthritis and foot deformities
For obvious injuries involving diastasis subluxation or dislocation the diagnosis is relatively easy to establish using any imaging modality However for subtle injuries without gross bone separation a dynamic imaging modality facilitating weight-bearing are to be preferred Many consider weight-bearing conventional radiography as the current gold standard in acute Lisfranc injury diagnostics However conventional radiography is a 2D technique that can neither display nor measure the true dimensions of a detailed 3D object such as the tarsal bones in the foot Computed tomography CT provides greater accuracy in visualizing bone microarchitecture In combination with weight-bearing it can be ideal for detecting minor fractures and occult instability caused by loadstress
To this day there are no prospective studies comparing weight-bearing CT and weight-bearing radiography for acute Lisfranc injuries In the current study participants will be assigned to non-operative or operative treatment based on Lisfranc joint stability evaluation by the initial weight-bearing CT
For obvious injuries involving diastasis subluxation or dislocation the diagnosis is relatively easy to establish using any imaging modality However for subtle injuries without gross bone separation a dynamic imaging modality facilitating weight-bearing are to be preferred Many consider weight-bearing conventional radiography as the current gold standard in acute Lisfranc injury diagnostics However conventional radiography is a 2D technique that can neither display nor measure the true dimensions of a detailed 3D object such as the tarsal bones in the foot Computed tomography CT provides greater accuracy in visualizing bone microarchitecture In combination with weight-bearing it can be ideal for detecting minor fractures and occult instability caused by loadstress
To this day there are no prospective studies comparing weight-bearing CT and weight-bearing radiography for acute Lisfranc injuries In the current study participants will be assigned to non-operative or operative treatment based on Lisfranc joint stability evaluation by the initial weight-bearing CT
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?:
None