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Completed

NCT Number: NCT06048991

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

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.

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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Arthritis Joint Diseases Knee Injuries Leg Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Thermographic assessment

Diagnostic Test

Patients will undergo a termographic evaluation of the operated knee of ACL reconstruction and of the controlateral knee.

Primary outcomes

  1. Total knee temperature

    Time frame: baseline

    By thermographic analysis, the average skin temperature of the entire knee will be assessed, as well as the minimum temperature and maximum temperature.

  2. Temperature of the knee regions of interest

    Time frame: baseline

    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.

  3. The Tegner Activity Level Scale

    Time frame: baseline

    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.

  4. IKDC-Subjective Score (Subjective International Knee Documentation Committee)

    Time frame: baseline

    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.

  5. Objective parameters - Circumferences

    Time frame: baseline

    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

  6. Objective parameters- Range of Motion

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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