- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119804
Early Discrimination of Periprosthetic Hip Infections Using Neural Networks (SEPTIC-ANNR) (SEPTIC-ANNR)
Early Discrimination of Periprosthetic Hip Infections Using Neural Networks: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Periprosthetic hip infections are an hot topic in orthopedic surgery, whose incidence is about 1%. The morbidity, mortality and additional costs associated with prolonged hospitalization and further treatments are the main concerns. Periprosthetic infections are generally diagnosed using the CDC (Center for Disease Control and Prevention) criteria (2014). The diagnosis is based on major and minor criteria, including pre-operative and intra-operative parameters. In order to achieve a reliable diagnosis of infection, when fistula are not present, synovial fluid aspiration or tissue samples are required. However, these techniques are expensive and invasive. Moreover, sensitivity is not always so accurate, as shown by some series of revision surgeries performed for presumed aseptic loosening, which turned out to be septic after cultures. Therefore, diagnosis of infection often occurs late and after a long, complex, expensive and not always decisive diagnostic workup, impacting on the timing and success of the treatment.
A practical, rapid, reliable and non-invasive (possibly outpatient) diagnostic procedure for periprosthetic infections would be desirable. It may rely on diagnostic imaging, limiting the collection of liquid or tissues to doubtful cases. Currently, CT and nuclear medicine imaging techniques are not routinely adopted in the diagnosis of infection, due to the modest reliability, costs and exposure to radiant agents.
Recently, neural networks have been introduced: they consist of many simple parallel processors, deeply connected, realizing a computational model. Neural networks mimic brain and its ability to learn. Computational models recognize of visual signals, manage complex situations in real time, classify and manage noise, use associative memory with real-time access to large amounts of data and reconstruct partial or corrupted information. Neural networks have been already used to predict the onset of infections, metastases and treatment failures, integrating clinical and diagnostic imaging data. To date, no studies about neural networks in periprosthetic infection have been conducted. The purpose of this study is to evaluate whether neural networks (cellular neural networks-genetic algorithm), applied to conventional radiographies, are accurate, sensitive and specific for the early-discrimination of a periprosthetic hip infection, already diagnosed with well-recognized methods (CDC 2014).
Specifically, a population of patients, with a complete radiographic history (pre-operative X-rays and a series of other post-operative X-rays), treated for septic or aseptic loosening, is selected.
Both cases are necessary to "instruct" a neural network. The first step consists in identifying a consecutive series of patients with septic or aseptic loosening diagnosis, consulting the hospital database. Thus, patients are categorically divided into septic, or aseptic, loosening. The 2014 CDC criteria are used (as routinely performed in the clinical setting), adding another major and necessary criterion: at least 3 positive intraoperative tissue samples (same micro-organism). In case of aseptic loosening, the case must not meet the CDC 2014 criteria. Thus, the imaging and clinical data of the patients are collected. Having ascertained the diagnosis, the radiographic material is processed (cellular neural networks-genetic algorithm). The proposed procedure processes the radiographic images using the following pipeline and the MatLab software (Mathworks, Natick, US):
- baseline: the first post-implant image is compared to the pre-implant radiographic image;
- progresses are recorded by periodical radiographs using standard and repeatable projections (pelvis X-rays);
- the features are extracted from each image, in the manually segmented area (region of interest - ROI). Three steps take place: 1) image pre-processing, to create uniform frameworks of input data (gray-level images). Color Histogram Equalization; 2) features extracted from neural networks are applied to ROI. Cloning templates using genetic algorithms. The features will be processed by a fully connected layer + SoftMax; 3) features extracted from AutoEconder with fully-connected layer + SoftMax;
- analysis of differential radiographic features (analysis of cellular and convolutive sides) and comparison to the baseline. Post-processing in the following way: 1) fully-connected regression layer and multiclass classifier: will produce the percentage of septic progression risk; 2) fully-connected regression layer and binary classifier: features in the septic / aseptic clusters;
- a final decision tree: fusion of the above-mentioned data, providing a percentage of septic progression risk at the indexed imaging. The aim is to verify whether the neural networks applied to radiographic imaging can accurately, sensitively and specifically recognize a late, chronic periprosthetic hip infection diagnosed according to validated and certain criteria.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Enrico Tassinari, MD
- Phone Number: +390516366148
- Email: enrico.tassinari@ior.it
Study Contact Backup
- Name: Francesco Castagnini, MD
- Phone Number: +390516366148
- Email: francescocastagnini@hotmail.it
Study Locations
-
-
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Bologna, Italy, 40136
- Recruiting
- IRCCS Istituto Ortopedico Rizzoli
-
Contact:
- Enrico Tassinari, MD
- Phone Number: +390516366148
- Email: enrico.tassinari@ior.it
-
Contact:
- Francesco Castagnini, MD
- Phone Number: +390516366148
- Email: francescocastagnini@hotmail.it
-
Sub-Investigator:
- Francesco Rundo, BS
-
Sub-Investigator:
- Sabrina Conoci, BS
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Revisions of primary total hip arthroplasty due to septic and aseptic loosening
- In case of septic loosening, diagnosis of late chronic periprosthetic hip infection
- Complete clinical data
- Complete lab data (pre-revision erythrocyte sedimentation rate and C-reactive protein, at least 5 intraoperative tissue samples).
- Complete radiographic assessment (pre-implant X-ray, a series of post-operative X-rays, pre-revision X-ray)
Exclusion criteria
- Hip re-revisions
- Incomplete or inadequate radiographic assessment
- Inadequate data to diagnose infection according to 2014 CDC criteria and tissue samples
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
septic loosening
Septic loosening of primary hip implants according to the 2014 CDC criteria (as routinely performed in the clinical setting), adding another major and necessary criterion: at least 3 positive intraoperative tissue samples (same micro-organism).
|
Cellular neural networks-genetic algorithm applied to conventional radiographs of hip implants with a well-established diagnosis of loosening.
The study is not intended to use a software without a CE mark as a medical device, or to use the software as a tool to diagnose or prevent human disease, according to Directive 93/42 / European Economic Community.
The study will evaluate if the software, properly calibrated, is able to recognize with adequate accuracy infections already diagnosed with validated methods.
|
aseptic loosening
aseptic loosening of primary hip implants not meeting the CDC 2014 criteria
|
Cellular neural networks-genetic algorithm applied to conventional radiographs of hip implants with a well-established diagnosis of loosening.
The study is not intended to use a software without a CE mark as a medical device, or to use the software as a tool to diagnose or prevent human disease, according to Directive 93/42 / European Economic Community.
The study will evaluate if the software, properly calibrated, is able to recognize with adequate accuracy infections already diagnosed with validated methods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy
Time Frame: 15 years
|
Definition: ability of the cellular neural network to discriminate between septic and aseptic loosening. Technique: the diagnostic accuracy will be measured as a receiver operating characteristic (ROC) curve, according to the maximum likelihood method (binomial approximation). Metric: percentage. Minimum-maximum values: 0-100. |
15 years
|
Sensitivity
Time Frame: 15 years
|
Definition: the probability of being septic in septic hips with ascertained CDC criteria. Technique: true positive / (true positive + false negative). Metric: percentage. Minimum-maximum values: 0-100. |
15 years
|
Specificity
Time Frame: 15 years
|
Definition: proportion of aseptic loosening in total of aseptic loosening ascertained using CDC criteria Technique: True negative / (true negative + false positive) Metric: percentage.
Minimum-maximum values: 0-100.
|
15 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Francesco Traina, PhD, IRCCS Istituto Ortopedico Rizzoli
Publications and helpful links
General Publications
- Verberne SJ, Raijmakers PG, Temmerman OP. The Accuracy of Imaging Techniques in the Assessment of Periprosthetic Hip Infection: A Systematic Review and Meta-Analysis. J Bone Joint Surg Am. 2016 Oct 5;98(19):1638-1645. doi: 10.2106/JBJS.15.00898.
- Peel TN, Spelman T, Dylla BL, Hughes JG, Greenwood-Quaintance KE, Cheng AC, Mandrekar JN, Patel R. Optimal Periprosthetic Tissue Specimen Number for Diagnosis of Prosthetic Joint Infection. J Clin Microbiol. 2016 Dec 28;55(1):234-243. doi: 10.1128/JCM.01914-16. Print 2017 Jan.
- Bargon R, Bruenke J, Carli A, Fabritius M, Goel R, Goswami K, Graf P, Groff H, Grupp T, Malchau H, Mohaddes M, Novaes de Santana C, Phillips KS, Rohde H, Rolfson O, Rondon A, Schaer T, Sculco P, Svensson K. General Assembly, Research Caveats: Proceedings of International Consensus on Orthopedic Infections. J Arthroplasty. 2019 Feb;34(2S):S245-S253.e1. doi: 10.1016/j.arth.2018.09.076. Epub 2018 Oct 19. No abstract available.
- Abdel Karim M, Andrawis J, Bengoa F, Bracho C, Compagnoni R, Cross M, Danoff J, Della Valle CJ, Foguet P, Fraguas T, Gehrke T, Goswami K, Guerra E, Ha YC, Klaber I, Komnos G, Lachiewicz P, Lausmann C, Levine B, Leyton-Mange A, McArthur BA, Mihalic R, Neyt J, Nunez J, Nunziato C, Parvizi J, Perka C, Reisener MJ, Rocha CH, Schweitzer D, Shivji F, Shohat N, Sierra RJ, Suleiman L, Tan TL, Vasquez J, Ward D, Wolf M, Zahar A. Hip and Knee Section, Diagnosis, Algorithm: Proceedings of International Consensus on Orthopedic Infections. J Arthroplasty. 2019 Feb;34(2S):S339-S350. doi: 10.1016/j.arth.2018.09.018. Epub 2018 Oct 19. No abstract available.
- Chotanaphuti T, Courtney PM, Fram B, In den Kleef NJ, Kim TK, Kuo FC, Lustig S, Moojen DJ, Nijhof M, Oliashirazi A, Poolman R, Purtill JJ, Rapisarda A, Rivero-Boschert S, Veltman ES. Hip and Knee Section, Treatment, Algorithm: Proceedings of International Consensus on Orthopedic Infections. J Arthroplasty. 2019 Feb;34(2S):S393-S397. doi: 10.1016/j.arth.2018.09.024. Epub 2018 Oct 19. No abstract available.
- Amanatullah D, Dennis D, Oltra EG, Marcelino Gomes LS, Goodman SB, Hamlin B, Hansen E, Hashemi-Nejad A, Holst DC, Komnos G, Koutalos A, Malizos K, Martinez Pastor JC, McPherson E, Meermans G, Mooney JA, Mortazavi J, Parsa A, Pecora JR, Pereira GA, Martos MS, Shohat N, Shope AJ, Zullo SS. Hip and Knee Section, Diagnosis, Definitions: Proceedings of International Consensus on Orthopedic Infections. J Arthroplasty. 2019 Feb;34(2S):S329-S337. doi: 10.1016/j.arth.2018.09.044. Epub 2018 Oct 19. No abstract available.
- Ting NT, Della Valle CJ. Diagnosis of Periprosthetic Joint Infection-An Algorithm-Based Approach. J Arthroplasty. 2017 Jul;32(7):2047-2050. doi: 10.1016/j.arth.2017.02.070. Epub 2017 Mar 2.
- Heckerling PS, Canaris GJ, Flach SD, Tape TG, Wigton RS, Gerber BS. Predictors of urinary tract infection based on artificial neural networks and genetic algorithms. Int J Med Inform. 2007 Apr;76(4):289-96. doi: 10.1016/j.ijmedinf.2006.01.005. Epub 2006 Feb 15.
- Yamashita R, Nishio M, Do RKG, Togashi K. Convolutional neural networks: an overview and application in radiology. Insights Imaging. 2018 Aug;9(4):611-629. doi: 10.1007/s13244-018-0639-9. Epub 2018 Jun 22.
- Fazal MI, Patel ME, Tye J, Gupta Y. The past, present and future role of artificial intelligence in imaging. Eur J Radiol. 2018 Aug;105:246-250. doi: 10.1016/j.ejrad.2018.06.020. Epub 2018 Jun 22.
- Osmon DR, Berbari EF, Berendt AR, Lew D, Zimmerli W, Steckelberg JM, Rao N, Hanssen A, Wilson WR; Infectious Diseases Society of America. Diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jan;56(1):e1-e25. doi: 10.1093/cid/cis803. Epub 2012 Dec 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 438/2019/Oss/IOR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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