NCT06009601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 9, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

January 11, 2023

Last Update Submit

August 20, 2023

Conditions

Keywords

Pectus ExcavatumPectus CarinatumScoliosisKyphosisLordosis

Outcome Measures

Primary Outcomes (3)

  • Pectus Study Form

    In the Pectus Study Form, the clinical and radiological data of the patient will be evaluated. Coronal, sagittal balance and coronal and sagittal cobb angles of the patient will be measured in the scoliosis X-ray.

    Within 1 week of applying to the scoliosis outpatient clinic

  • Pulmonary Function Test (PFT)

    Pulmonary function test measurements will be made for people with pectus deformity.Pulmonary function tests, or PFTs, measure how well the lungs work. For some of the test measurements, the client can breathe normally and quietly. Other tests require forced inhalation or exhalation after a deep breath. Sometimes, they will be asked to inhale a different gas or a medicine to see how it changes test results.

    Within 1 week of applying to the scoliosis outpatient clinic

  • Body Aesthetic Clinical Evaluation (TRACE)

    Body Aesthetic Clinical Evaluation (TRACE) measurement will be performed.TRACE is a 12-point scale based on four sub-scales, shoulders (0-3), scapulae (0-2), hemi-thorax (0-2) and waist (0-4)

    Within 1 week of applying to the scoliosis outpatient clinic

Secondary Outcomes (7)

  • Quality of Life Evaluation Form in Pectus Deformity

    Within 1 week of applying to the scoliosis outpatient clinic

  • Social Comparison Scale

    Within 1 week of applying to the scoliosis outpatient clinic

  • Sleep Disorder Scale for Children

    Within 1 week of applying to the scoliosis outpatient clinic

  • Anxiety Disorders Screening Scale in Children

    Within 1 week of applying to the scoliosis outpatient clinic

  • The Pediatric Quality of Life Inventory

    Within 1 week of applying to the scoliosis outpatient clinic

  • +2 more secondary outcomes

Study Arms (1)

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.

Diagnostic Test: Pectus Study FormDiagnostic Test: Adams TestDiagnostic Test: Scoliosis GraphyDiagnostic Test: Pulmonary function test

Interventions

Pectus Study FormDIAGNOSTIC_TEST

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.

Patients aged 3-18 years who were diagnosed with pectus deformity
Adams TestDIAGNOSTIC_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

Also known as: Forward Bending Test
Patients aged 3-18 years who were diagnosed with pectus deformity
Scoliosis GraphyDIAGNOSTIC_TEST

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.

Also known as: Orthoroentgenogram
Patients aged 3-18 years who were diagnosed with pectus deformity

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.

Also known as: Spirometry Function Test
Patients aged 3-18 years who were diagnosed with pectus deformity

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deniz

Gaziosmanpaşa, Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

MeSH Terms

Conditions

Funnel ChestPectus CarinatumScoliosisKyphosisLordosis

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCartilage DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSpinal CurvaturesSpinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Meryem Guneser Gulec, MD

    Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department

    STUDY CHAIR
  • Ebru Yilmaz Yalcinkaya, Prof

    Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

August 24, 2023

Study Start

March 9, 2023

Primary Completion

April 9, 2023

Study Completion

April 28, 2023

Last Updated

August 24, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.

Locations