Clinical trial NCT06009601: The Relationship Between Pectus Deformities and Spinal Pathologies
Official title: Are Pectus Deformities a Projection of Spinal Pathologies?The Relationship Between Pectus Deformities and Spinal Pathologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pectus Deformity of Chest
Spinal Deformity
Keywords: Pectus Excavatum
Pectus Carinatum
Scoliosis
Kyphosis
Lordosis
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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. Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 5 degrees in those with BMI (Body Mass Index) above 85%. If it is below 85% and above 7 degrees, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis film will be requested. Scoliosis X-ray (orthorontgenogram) will be requested. Coronal, sagittal balance, coronal and sagittal cobb angles will be measured. Their relationship with chest deformities will be evaluated. All measurements will be made and recorded by two independent researchers.

Brief summary: Pectus deformities are common anterior chest wall pathologies. Pectus excavatum is the most common chest deformity with an incidence of 0.1-0.3%. Although the incidence of adolescent idiopathic scoliosis (AIS) is 0.2-3% in the community, some studies show that this rate rises to 17.61-25.58% when it is associated with pectus deformity. While the pectus excavatum rotates the heart to the left with its ribs and cartilages, it pushes the thoracic vertebra to the right side with the internal counterforce created by the heart, which has been shown to push the spine to the right with an asymmetric horizontal force in scoliosis patients with pectus deformity.

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.

Detailed description: The study was planned as a prospective cross-sectional study. Pectus study forms consisting of clinical and radiological measurements of the patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail, and the Adams test (forward bending test) (+) will be measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation- trunk rotation) measurements. If ATR measurement is above 7 degrees on Bunnell scoliometer, patients who meet the inclusion criteria will be included in the study by filling in the informed consent form and a scoliosis radiograph will be requested (Independent of investigators' study, it is necessary to withdraw it in line with the 2016 recommendations of the International Scientific Society for Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT).)

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.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with pectus deformity
* Be between 3-18 years old

Exclusion Criteria:

* Adult type scoliosis
* 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.

Primary outcomes:
measure: Pectus Study Form
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
measure: Pulmonary Function Test (PFT)
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
measure: Body Aesthetic Clinical Evaluation (TRACE)
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
Secondary outcomes:
measure: Quality of Life Evaluation Form in Pectus Deformity
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
measure: Social Comparison Scale
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
measure: Sleep Disorder Scale for Children
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
measure: Anxiety Disorders Screening Scale in Children
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
measure: The Pediatric Quality of Life Inventory
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
measure: Scoliosis Research Society Score
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
measure: Beck Anxiety Scale
timeFrame: Within 1 week of applying to the scoliosis outpatient clinic
Other outcomes:
Locations:
city: Gazi̇osmanpaşa
country: Turkey
facility: Deniz
state: İstanbul
Study officials:
affiliation: Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
name: Meryem Guneser Gulec, MD
role: STUDY_CHAIR
affiliation: Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
name: Ebru Yilmaz Yalcinkaya, Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.