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Evaluation of Thermographic Images of the Knee in Patients With Anterior Cruciate Ligament Reconstruction Outcome

Primary Purpose

ACL Injury

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Thermographic assessment
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ACL Injury focused on measuring ACL reconstruction, Anterior cruciate ligament, infrared thermography, joint inflammation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients aged between 18 and 40 years; Asymptomatic at the time of evaluation (IKDC ≥95); No history of previous surgery or contralateral knee fractures; No history of direct or indirect trauma in the previous six months to either knee; Absence of gonalgia (VAS pain equal to 0) at evaluation; BMI between 18.5 kg/m2 and 29.9 kg/m2. Exclusion Criteria: Patients who are incapacitated or have neurological disorders that may invalidate the research protocol; Diagnosis of leukemia, known presence of metastatic malignant cells, current or planned chemotherapy; Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis; Patients with uncontrolled diabetes mellitus; Patients with uncontrolled thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs, or medications;

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Knees termographic evaluation

Arm Description

All 30 patients will undergo thermographic evaluation of the operated knee of ACL reconstruction and of the controlateral knee.

Outcomes

Primary Outcome Measures

Total knee temperature
By thermographic analysis, the average skin temperature of the entire knee will be assessed, as well as the minimum temperature and maximum temperature.
Temperature of the knee regions of interest
The mean skin temperature will be assessed, as well as the minimum and maximum temperature of the regions of interest in the knee, divided into medial, lateral, patellar and supra patellar areas.
The Tegner Activity Level Scale
The Tegner Activity Level Scale: allows the estimation of a subject's motor activity level with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as soccer at the national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders.
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
The IKDC-Subjective Score (Subjective International Knee Documentation Committee) is a subjective, knee-specific rating scale.The questionnaire examines 3 categories: symptoms, sports activity, and knee function. The response "Unable to perform any of the above activities due to knee pain" receives a score of 0 while the response "Very strenuous activities like jumping or pivoting as in basketball or soccer" receives a score of 4. This is how item 1, which is related to the highest level of activity without significant pain, is scored. For item 2, which asks about the frequency of pain in the last four weeks, the responses "Constant" and "Never" receive scores of 0 and 10, respectively. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100.If there is a score of 100, it means that there is no restrictions on the daily activities or athletic endeavors and doesn't experience any symptoms.
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis.The measurement will be taken by the orthopedist by meter and will be reported in centimeters
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis. Range of motion (ROM) is a term used to describe how far you can move a joint or muscle in various directions. It is used to measure how much you can move a joint on your own (active ROM) or with the assistance of someone else (passive ROM).Range of motion is measured using a goniometer.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2023
Last Updated
September 27, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT06048991
Brief Title
Evaluation of Thermographic Images of the Knee in Patients With Anterior Cruciate Ligament Reconstruction Outcome
Official Title
Evaluation of Thermographic Images of the Knee in Patients With Anterior Cruciate Ligament Reconstruction Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 patient's Informed Consent has been obtained, the patient will wait sitting 10 minutes inside the temperature-controlled room of 23°C, 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 exercise.Once 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
ACL reconstruction, Anterior cruciate ligament, infrared thermography, joint inflammation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Knees termographic evaluation
Arm Type
Experimental
Arm Description
All 30 patients will undergo thermographic evaluation of the operated knee of ACL reconstruction and of the controlateral knee.
Intervention Type
Diagnostic Test
Intervention Name(s)
Thermographic assessment
Intervention Description
Patients will undergo a termographic evaluation of the operated knee of ACL reconstruction and of the controlateral knee.
Primary Outcome Measure Information:
Title
Total knee temperature
Description
By thermographic analysis, the average skin temperature of the entire knee will be assessed, as well as the minimum temperature and maximum temperature.
Time Frame
baseline
Title
Temperature of the knee regions of interest
Description
The mean skin temperature will be assessed, as well as the minimum and maximum temperature of the regions of interest in the knee, divided into medial, lateral, patellar and supra patellar areas.
Time Frame
baseline
Title
The Tegner Activity Level Scale
Description
The Tegner Activity Level Scale: allows the estimation of a subject's motor activity level with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as soccer at the national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders.
Time Frame
baseline
Title
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
Description
The IKDC-Subjective Score (Subjective International Knee Documentation Committee) is a subjective, knee-specific rating scale.The questionnaire examines 3 categories: symptoms, sports activity, and knee function. The response "Unable to perform any of the above activities due to knee pain" receives a score of 0 while the response "Very strenuous activities like jumping or pivoting as in basketball or soccer" receives a score of 4. This is how item 1, which is related to the highest level of activity without significant pain, is scored. For item 2, which asks about the frequency of pain in the last four weeks, the responses "Constant" and "Never" receive scores of 0 and 10, respectively. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100.If there is a score of 100, it means that there is no restrictions on the daily activities or athletic endeavors and doesn't experience any symptoms.
Time Frame
baseline
Title
Objective parameters - Circumferences
Description
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis.The measurement will be taken by the orthopedist by meter and will be reported in centimeters
Time Frame
baseline
Title
Objective parameters- Range of Motion
Description
Evaluation of the Range of Motion for comparative analysis. Range of motion (ROM) is a term used to describe how far you can move a joint or muscle in various directions. It is used to measure how much you can move a joint on your own (active ROM) or with the assistance of someone else (passive ROM).Range of motion is measured using a goniometer.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged between 18 and 40 years; Asymptomatic at the time of evaluation (IKDC ≥95); No history of previous surgery or contralateral knee fractures; No history of direct or indirect trauma in the previous six months to either knee; Absence of gonalgia (VAS pain equal to 0) at evaluation; BMI between 18.5 kg/m2 and 29.9 kg/m2. Exclusion Criteria: Patients who are incapacitated or have neurological disorders that may invalidate the research protocol; Diagnosis of leukemia, known presence of metastatic malignant cells, current or planned chemotherapy; Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis; Patients with uncontrolled diabetes mellitus; Patients with uncontrolled thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs, or medications;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Di Martino, MD
Phone
0516366567
Email
alessandro.dimartino@ior.it
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Licciardi, MSc
Phone
6366567
Ext
051
Email
roberta.licciardi@ior.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Di Martino, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Di Martino, MD
Phone
6366567
Ext
051
Email
alessandro.dimartino@ior.it
First Name & Middle Initial & Last Name & Degree
Roberta Licciardi, MSc
Phone
6366567
Ext
051
Email
roberta.licciardi@ior.it

12. IPD Sharing Statement

Citations:
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Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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Evaluation of Thermographic Images of the Knee in Patients With Anterior Cruciate Ligament Reconstruction Outcome

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