Impact of Risser Stage on Pressure of Correction in Pectus Carinatum

NCT03548922 | Unknown

• 1 other identifier: 09.2018.327
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Pectus carinatum (PC) is a deformity of the anterior chest wall which is a common pediatric condition, characterized by an idiopathic overgrowth of the costal cartilages resulting in protrusion of the sternum. Knowing factors influencing pressure of correction may lead successful treatment outcomes. In a study by Lee and colleagues investigating the effectiveness of the orthosis, it was found that patients with advanced Tanner stage of pubertal development had a longer time for correction of deformity. Martinez-Ferro et al proposed that pectus carinatum may return mildly, in approximately 10% of cured patients, particularly if they have been treated before pubertal growth spurts or in case they have cured very rapidly. To the best of our knowledge factors influencing pressure of correction and treatment outcomes after compressive bracing have not been investigated before. Our aim is to investigate impact of Risser stage on pressure of correction in PC.

Conditions

Pectus Carinatum

Keywords

Risser; Tanner; pressure of correction

Outcome Measures

Primary Outcomes (1)

• Risser (a measure showing the growth left in the spine)

  stage 0: no ossification center at the level of iliac crest apophysis stage 1: apophysis under 25% of the iliac crest stage 2: apophysis over 25-50% of the iliac crest stage 3: apophysis over 50-75% of the iliac crest stage 4: apophysis over \>75% of the iliac crest stage 5: complete ossification and fusion of the iliac crest apophysis

  Day 0

Secondary Outcomes (3)

• Tanner (a scale of physical pubertal development in children, adolescents and adults)

  Day 0

• pressure of correction (an indirect parameter of the chest wall's flexibility. It is defined as the pressure applied to the patient, in the most protruding area of the chest, needed to accomplish a proper shape of the thorax)

  Day 0

• Pectus carinatum protrusion (distance from the point of maximum protrusion to the estimated normal level of chest wall)

  Day 0

Study Arms (1)

Pectus carinatum

Demographic data (age, sex), pressure of correction, Tanner stage, Risser stage, Haller index, pectus carinatum protrusion measurements of patients with pectus carinatum will be recorded and association of them with pressure of correction will be investigated.

Other: Tanner stage; Other: Risser stage; Other: Pressure of correction; Other: Pectus carinatum protrusion

Interventions

Tanner stage OTHER

a scale of pubertal development in children, adolescents

Pectus carinatum

Risser stage OTHER

a measure showing the growth left in the spine

Pectus carinatum

Pressure of correction OTHER

an indirect parameter of the chest wall's flexibility. It is defined as the pressure applied to the patient, in the most protruding area of the chest, needed to accomplish a proper shape of the thorax.

Pectus carinatum

Pectus carinatum protrusion OTHER

distance from the point of maximum protrusion to the estimated normal level of chest wall

Pectus carinatum

Eligibility Criteria

• Age: 5 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with pectus carinatum who never experienced brace before

You may qualify if:

• Chondro-gladiolar pectus carinatum (PC)
• Patients with PC between the ages of 8-24 years

You may not qualify if:

• Patients who previously used compression brace
• Chondro-manubrial PC
• Severe scoliosis (Cobb angle\>20 degrees)
• Systemic chronic disease
• Complex anomaly, PC as a part of syndrome
• he history of surgical correction of scoliosis or pectus deformity.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Fokin AA, Steuerwald NM, Ahrens WA, Allen KE. Anatomical, histologic, and genetic characteristics of congenital chest wall deformities. Semin Thorac Cardiovasc Surg. 2009 Spring;21(1):44-57. doi: 10.1053/j.semtcvs.2009.03.001.

  PMID: 19632563 BACKGROUND

• Martinez-Ferro M, Bellia Munzon G, Fraire C, Abdenur C, Chinni E, Strappa B, Ardigo L. Non-surgical treatment of pectus carinatum with the FMF(R) Dynamic Compressor System. J Vis Surg. 2016 Mar 17;2:57. doi: 10.21037/jovs.2016.02.20. eCollection 2016.

  PMID: 29078485 BACKGROUND

• Kravarusic D, Dicken BJ, Dewar R, Harder J, Poncet P, Schneider M, Sigalet DL. The Calgary protocol for bracing of pectus carinatum: a preliminary report. J Pediatr Surg. 2006 May;41(5):923-6. doi: 10.1016/j.jpedsurg.2006.01.058.

  PMID: 16677884 BACKGROUND

• de Beer SA, Gritter M, de Jong JR, van Heurn ELW. The Dynamic Compression Brace for Pectus Carinatum: Intermediate Results in 286 Patients. Ann Thorac Surg. 2017 Jun;103(6):1742-1749. doi: 10.1016/j.athoracsur.2016.12.019. Epub 2017 Mar 6.

  PMID: 28274516 BACKGROUND

• Lee RT, Moorman S, Schneider M, Sigalet DL. Bracing is an effective therapy for pectus carinatum: interim results. J Pediatr Surg. 2013 Jan;48(1):184-90. doi: 10.1016/j.jpedsurg.2012.10.037.

  PMID: 23331813 BACKGROUND

• Kang DY, Jung J, Chung S, Cho J, Lee S. Factors affecting patient compliance with compressive brace therapy for pectus carinatum. Interact Cardiovasc Thorac Surg. 2014 Dec;19(6):900-3. doi: 10.1093/icvts/ivu280. Epub 2014 Aug 27.

  PMID: 25164133 BACKGROUND

• http://www0.sun.ac.za/ortho/webct-ortho/age/risser.html -].

  BACKGROUND

MeSH Terms

Conditions

Pectus Carinatum

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Cartilage Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mustafa Yuksel, Prof

  Marmara University

  STUDY CHAIR

• Gulseren Akyuz, Prof

  Marmara University

  STUDY DIRECTOR

• Esra Giray, MD

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Giray, MD

CONTACT

05558134394; girayesra@hotmail.com

Onur Ermenak, Asist Prof

CONTACT

+905337141463; noermerak@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: June 7, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)