Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06048991
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2023-09-15
Brief Title:
Evaluation of Thermographic Images of the Knee in Patients With Anterior Cruciate Ligament Reconstruction Outcome
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Evaluation of Thermographic Images of the Knee in Patients With Anterior Cruciate Ligament Reconstruction Outcome
Status:
COMPLETED
Status Verified Date:
2024-08
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:
The Thermo-LCA study is a diagnostic interventional study for assessment of knee temperature of asymptomatic patients with ACL reconstruction compared with unoperated healthy contralateral knee The aim of the study is to analyze thermographic images obtained from the knees of asymptomatic patients with ACL reconstruction that occurred between the previous 2 and 5 years to assess the presence of inflammation in the knee with reconstructed ACL compared with the contralateral
Detailed Description:
Thermo-LCA study involves recruitment of thirty volunteers with unilateral ACL reconstruction Will be enrolled subjects aged 18 to 40 years with no history of previous surgery or chronic gonalgia in the contralateral knee Once the patients Informed Consent has been obtained the patient will wait sitting 10 minutes inside the temperature-controlled room of 23C a thermographic assessment will then be performed using a FLIRT1020 thermal imaging camera Photographs will be acquired in anteroposterior right lateral left lateral and posteroanterior views of both knees The patient will then perform a knee flexion-extension exercise against resistance for 2 minutes using a 2 kg weighted ankle monitor The speed at which this exercise is performed will be constant for all subjects with one repetition per second per leg Following this exercise four more thermographic images identical to the first will be acquired Basal thermographic assessments will be performed at 5 10 and 20 minutes after the end of the exerciseOnce the images are acquired these will be analyzed using ResearchIR software regions of interest of the knees will then be constructed and their temperature change over the various acquisitions and how it changes after physical exertion will then be analyzed
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