The Relationship Between Pectus Deformities and Spinal Pathologies
NCT ID: NCT06009601
Last Updated: 2023-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
40 participants
OBSERVATIONAL
2023-03-09
2023-04-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Based on this, in study, investigators aimed to determine whether there is any relationship between pectus deformities and spinal pathologies, and if there is a relationship, with which pathology it is most common, whether the type of scoliosis seen in pectus deformities with a prominent scoliosis prevalence is a pectus-specific curve, and whether this curve seen in scoliosis is associated with pectus. To determine whether there is a footprint or not.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity
NCT06392984
Chest Wall Deformities in Children - Epidemiological Data
NCT04448574
SPAIN Chest Wall Deformity Project (Pectus Repair)
NCT02098681
Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis
NCT04092335
Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum
NCT04185870
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Coronal, sagittal balance, coronal and sagittal cobb angles will be measured from the scoliosis radiograph taken from the Posterior-Anterior (PA) (posterior-anterior) and lateral (side) films. Their relationship with chest deformities will be evaluated. All measurements will be made and recorded by two independent investigators As a result of the analysis, when the power is targeted as 95% and the error amount as 0.05, the minimum sample size required for investigators to find a significant difference between the means was determined as 36. Investigators formed a sample group of 40 people for our study, together with the fact that groups of 36 people were sufficient in terms of providing 95% power. Kappa statistical analysis will be used to determine intraobserver and interobserver variations.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients aged 3-18 years who were diagnosed with pectus deformity
Pectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail.
Pectus Study Form
Pectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail.
In addition, this study form includes 'Quality of Life Evaluation Form in Pectus Deformity', 'Social Comparison Scale', 'Sleep Disorder Scale for Children', 'Anxiety Disorders Screening Scale in Children', 'Pediatric Quality of Life Questionnaire' designed for patients and their relatives. PedsQL)', 'SRS-22 Patient Questionnaire', 'Beck Anxiety Scale' and 'Informed Consent Form' designed for patients and their relatives.
Adams Test
Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 7 degrees in patients who meet the inclusion criteria will be included in the study by filling out an informed consent form
Scoliosis Graphy
ATR (angle of trunk rotation) values above 7 degrees on bunnell scoliometer were determined. Afterwards, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis graphy will be requested.
Coronal, sagittal balance; coronal and sagittal cobb angles will be measured from posterior-anterior (PA) (posterior-anterior) and lateral (lateral) scoliosis radiographs.
Pulmonary function test
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders.
There are 2 types of disorders that cause problems with air moving in and out of the lungs:
Obstructive. This is when air has trouble flowing out of the lungs due to airway resistance. This causes a decreased flow of air.
Restrictive. This is when the lung tissue and/or chest muscles can't expand enough. This creates problems with air flow, mostly due to lower lung volumes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pectus Study Form
Pectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail.
In addition, this study form includes 'Quality of Life Evaluation Form in Pectus Deformity', 'Social Comparison Scale', 'Sleep Disorder Scale for Children', 'Anxiety Disorders Screening Scale in Children', 'Pediatric Quality of Life Questionnaire' designed for patients and their relatives. PedsQL)', 'SRS-22 Patient Questionnaire', 'Beck Anxiety Scale' and 'Informed Consent Form' designed for patients and their relatives.
Adams Test
Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 7 degrees in patients who meet the inclusion criteria will be included in the study by filling out an informed consent form
Scoliosis Graphy
ATR (angle of trunk rotation) values above 7 degrees on bunnell scoliometer were determined. Afterwards, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis graphy will be requested.
Coronal, sagittal balance; coronal and sagittal cobb angles will be measured from posterior-anterior (PA) (posterior-anterior) and lateral (lateral) scoliosis radiographs.
Pulmonary function test
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders.
There are 2 types of disorders that cause problems with air moving in and out of the lungs:
Obstructive. This is when air has trouble flowing out of the lungs due to airway resistance. This causes a decreased flow of air.
Restrictive. This is when the lung tissue and/or chest muscles can't expand enough. This creates problems with air flow, mostly due to lower lung volumes.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Be between 3-18 years old
Exclusion Criteria
* Congenital scoliosis
* Neuromuscular scoliosis
* Syndromic scoliosis
* Infantile idiopathic scoliosis
* Having surgery to the chest wall or spine
* People with connective tissue disease will not be included in the study.
3 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gaziosmanpasa Research and Education Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Meryem Guneser Gulec, MD
Role: STUDY_CHAIR
Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
Ebru Yilmaz Yalcinkaya, Prof
Role: STUDY_DIRECTOR
Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Deniz
Gaziosmanpaşa, Istanbul, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zhong W, Ye J, Feng J, Geng L, Lu G, Liu J, Zhang C. Effects of Pectus Excavatum on the Spine of Pectus Excavatum Patients with Scoliosis. J Healthc Eng. 2017;2017:5048625. doi: 10.1155/2017/5048625. Epub 2017 Jul 3.
Tomaszewski R, Wiktor L, Machala L. Evaluation of thoracic vertebrae rotation in patients with pectus excavatum. Acta Orthop Traumatol Turc. 2017 Jul;51(4):284-289. doi: 10.1016/j.aott.2017.03.005. Epub 2017 Jun 16.
Tauchi R, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A. Evaluation of thoracic factors after scoliosis surgery in patients with both scoliosis and pectus excavatum. Eur Spine J. 2018 Feb;27(2):381-387. doi: 10.1007/s00586-016-4753-4. Epub 2016 Aug 27.
Alaca N, Yuksel M. Comparison of physical functions and psychosocial conditions between adolescents with pectus excavatum, pectus carinatum and healthy controls. Pediatr Surg Int. 2021 Jun;37(6):765-775. doi: 10.1007/s00383-021-04857-7. Epub 2021 Jan 16.
Iscan M, Kilic B, Turna A, Kaynak MK. The effect of minimally invasive pectus excavatum repair on thoracic scoliosis. Eur J Cardiothorac Surg. 2020 Oct 30:ezaa328. doi: 10.1093/ejcts/ezaa328. Online ahead of print.
Tauchi R, Suzuki Y, Tsuji T, Ohara T, Saito T, Nohara A, Morishita K, Yamauchi I, Kawakami N. Clinical Characteristics and Thoracic factors in patients with Idiopathic and Syndromic Scoliosis Associated with Pectus Excavatum. Spine Surg Relat Res. 2018 Jan 27;2(1):37-41. doi: 10.22603/ssrr.2017-0027. eCollection 2018.
van Es LJM, van Royen BJ, Oomen MWN. Clinical significance of concomitant pectus deformity and adolescent idiopathic scoliosis: systematic review with best evidence synthesis. N Am Spine Soc J. 2022 Jun 25;11:100140. doi: 10.1016/j.xnsj.2022.100140. eCollection 2022 Sep.
Alaca N, Cagri Aslan D, Alaca I, Yuksel M. The psychometric properties of the Turkish version of the pectus carinatum body image quality of life questionnaire. Pediatr Surg Int. 2022 Jun;38(6):833-842. doi: 10.1007/s00383-022-05119-w. Epub 2022 Apr 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
397
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.