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

NCT06048991 | Completed

• 1 other identifier: Thermo-LCA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury

Keywords

ACL reconstruction; Anterior cruciate ligament; infrared thermography; joint inflammation

Outcome Measures

Primary Outcomes (6)

• 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.

  baseline

• 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.

  baseline

• 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.

  baseline

• 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.

  baseline

• 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

  baseline

• 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.

  baseline

Study Arms (1)

Knees termographic evaluation

EXPERIMENTAL

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

Diagnostic Test: Thermographic assessment

Interventions

Thermographic assessment DIAGNOSTIC_TEST

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

Knees termographic evaluation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (13)

• Moses B, Orchard J, Orchard J. Systematic review: Annual incidence of ACL injury and surgery in various populations. Res Sports Med. 2012 Jul;20(3-4):157-79. doi: 10.1080/15438627.2012.680633.

  PMID: 22742074 BACKGROUND

• Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.

  PMID: 26920430 BACKGROUND

• Mall NA, Chalmers PN, Moric M, Tanaka MJ, Cole BJ, Bach BR Jr, Paletta GA Jr. Incidence and trends of anterior cruciate ligament reconstruction in the United States. Am J Sports Med. 2014 Oct;42(10):2363-70. doi: 10.1177/0363546514542796. Epub 2014 Aug 1.

  PMID: 25086064 BACKGROUND

• Lie MM, Risberg MA, Storheim K, Engebretsen L, Oiestad BE. What's the rate of knee osteoarthritis 10 years after anterior cruciate ligament injury? An updated systematic review. Br J Sports Med. 2019 Sep;53(18):1162-1167. doi: 10.1136/bjsports-2018-099751. Epub 2019 Apr 1.

  PMID: 30936063 BACKGROUND

• Ajuied A, Wong F, Smith C, Norris M, Earnshaw P, Back D, Davies A. Anterior cruciate ligament injury and radiologic progression of knee osteoarthritis: a systematic review and meta-analysis. Am J Sports Med. 2014 Sep;42(9):2242-52. doi: 10.1177/0363546513508376. Epub 2013 Nov 8.

  PMID: 24214929 BACKGROUND

• Larsson S, Struglics A, Lohmander LS, Frobell R. Surgical reconstruction of ruptured anterior cruciate ligament prolongs trauma-induced increase of inflammatory cytokines in synovial fluid: an exploratory analysis in the KANON trial. Osteoarthritis Cartilage. 2017 Sep;25(9):1443-1451. doi: 10.1016/j.joca.2017.05.009. Epub 2017 May 15.

  PMID: 28522220 BACKGROUND

• Roemer FW, Englund M, Turkiewicz A, Struglics A, Guermazi A, Lohmander LS, Larsson S, Frobell R. Molecular and Structural Biomarkers of Inflammation at Two Years After Acute Anterior Cruciate Ligament Injury Do Not Predict Structural Knee Osteoarthritis at Five Years. Arthritis Rheumatol. 2019 Feb;71(2):238-243. doi: 10.1002/art.40687. Epub 2018 Dec 4.

  PMID: 30079991 BACKGROUND

• Romano CL, Logoluso N, Dell'Oro F, Elia A, Drago L. Telethermographic findings after uncomplicated and septic total knee replacement. Knee. 2012 Jun;19(3):193-7. doi: 10.1016/j.knee.2011.02.012. Epub 2011 Mar 26.

  PMID: 21441031 BACKGROUND

• Ramirez-GarciaLuna JL, Bartlett R, Arriaga-Caballero JE, Fraser RDJ, Saiko G. Infrared Thermography in Wound Care, Surgery, and Sports Medicine: A Review. Front Physiol. 2022 Mar 3;13:838528. doi: 10.3389/fphys.2022.838528. eCollection 2022.

  PMID: 35309080 BACKGROUND

• Dias de Lacerda AP, Rodrigues de Andrade P, Kamonseki DH, Parizotto NA, Alves da Silva AS, Bernardo de Medeiros L, de Almeida Ferreira JJ. Accuracy of infrared thermography in detecting tendinopathy: A systematic review with meta-analysis. Phys Ther Sport. 2022 Nov;58:117-125. doi: 10.1016/j.ptsp.2022.10.005. Epub 2022 Oct 10.

  PMID: 36274313 BACKGROUND

• Tan YK, Hong C, Li H, Allen JC Jr, Thumboo J. Thermography in rheumatoid arthritis: a comparison with ultrasonography and clinical joint assessment. Clin Radiol. 2020 Dec;75(12):963.e17-963.e22. doi: 10.1016/j.crad.2020.08.017. Epub 2020 Sep 13.

  PMID: 32938539 BACKGROUND

• Umapathy S, Thulasi R, Gupta N, Sivanadhan S. Thermography and colour Doppler ultrasound: a potential complementary diagnostic tool in evaluation of rheumatoid arthritis in the knee region. Biomed Tech (Berl). 2020 May 26;65(3):289-299. doi: 10.1515/bmt-2019-0051.

  PMID: 31821162 BACKGROUND

• Denoble AE, Hall N, Pieper CF, Kraus VB. Patellar skin surface temperature by thermography reflects knee osteoarthritis severity. Clin Med Insights Arthritis Musculoskelet Disord. 2010 Oct 15;3:69-75. doi: 10.4137/CMAMD.S5916.

  PMID: 21151853 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Arthritis

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Alessandro Di Martino, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: July 7, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

IT (1)