Dynamic Compression Brace for Pectus Carinatum

NCT03559244 | Completed

• 1 other identifier: 09.2018.328
• Study Type: interventional
• Target: 27
• 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. Chest pain or discomfort, especially when lying in prone position, increased respiratory effort during exercise, scoliosis, impaired shoulders and kyphotic position are some of the physical signs and symptoms. Unlike pectus excavatum, PC is rarely associated with significant cardiopulmonary involvement except in severe cases. Pectus carinatum is not just a simple aesthetical problem. The effect of patient's self-esteem, body image and confidence can be variable and lead to significant deterioration in mental health. It can be responsible of physical signs and symptoms and also has significant psychological impact. Deformity and its psychological impact tend to worsen during pubertal rapid phases of growth and even during adult life. The management of pectus deformities used to include surgical techniques, however, recently compression brace which is a dynamic orthosis which is custom-fitted, rigid aluminum brace that is adjustable to any thoracic shape is widely applied instead of surgery. Pressure applied to the patient, in the most protruding area of the chest, needed to accomplish a proper shape of the thorax, the pressure of correction can be measured via a pressure measuring device in pounds per square inches (PSI). Treatment choices of surgery or bracing is determined according to pressure of correction and type of deformity. Surgical correction is indicated if the presence of chondro-manubrial type PC and pressure of correction \> 10 PSI. Chest pain or discomfort, especially when lying in prone position, increased respiratory effort during exercise, scoliosis, impaired shoulders and kyphotic position are some of the physical signs and symptoms. Despite the fact that patients with PC have impaired posture, exercise intolerance and increased scoliosis occurrence, there is no consensus on the exercise program for patients with PC. Also, there is not enough scientific evidence about the wear time of orthosis. The aim of this study is to investigate the effects of exercises and compression brace in children with PC.

Conditions

Pectus Carinatum

Keywords

exercise; pectus carinatum; orthosis; dynamic compression brace

Outcome Measures

Primary Outcomes (2)

• Pectus carinatum protrusion

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

  Day 0

• Pectus carinatum protrusion

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

  3 weeks

Secondary Outcomes (22)

• T1 (external measurement of chest wall at the upper age of manubrium)

  Day 0

• T1 (external measurement of chest wall at the upper age of manubrium)

  3 weeks

• T2 (external measurement of chest wall at Angulus Ludovici)

  Day 0

• T2 (external measurement of chest wall at Angulus Ludovici)

  3 weeks

• T3 (external measurement of chest wall at the most protruded point from the chest wall)

  Day 0

Study Arms (3)

Dynamic compression brace 8 hours

EXPERIMENTAL

Children with pectus carinatum who will wear dynamic compression brace 8 hours a day plus exercises for three weeks

Other: Dynamic compression brace; Other: Exercises

Dynamic compression brace 23 hours

EXPERIMENTAL

Children with pectus carinatum who will wear dynamic compression brace 23 hours (except for bathing and sports activities) a day plus exercises for three weeks

Other: Dynamic compression brace; Other: Exercises

Only exercises

ACTIVE COMPARATOR

The children who are in wait in list for dynamic compression brace will receive only posture exercises, deep breathing exercises, exercises for manipulation and mobilization of ribs, and core exercises for three weeks

Other: Exercises

Interventions

Dynamic compression brace OTHER

custom-fitted brace adjusts the pressure on the thoracic wall and enables lateral expansion of the thorax

Dynamic compression brace 23 hours; Dynamic compression brace 8 hours

Exercises OTHER

posture exercises, deep breathing exercises, exercises for manipulation and mobilization of ribs, and core exercises

Dynamic compression brace 23 hours; Dynamic compression brace 8 hours; Only exercises

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male patients with pectus carinatum
• Symmetric or asymmetric pectus carinatum
• Compression test positive
• Pressure of correction \<10 PSI

You may not qualify if:

• History of orthosis use
• Chondro-manubrial pectus carinatum
• Concomitant severe scoliosis (Cobb angle\>20)
• Having history of chronic disease
• History of surgery for scoliosis or pectus carinatum

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (6)

• 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

• Banever GT, Konefal SH, Gettens K, Moriarty KP. Nonoperative correction of pectus carinatum with orthotic bracing. J Laparoendosc Adv Surg Tech A. 2006 Apr;16(2):164-7. doi: 10.1089/lap.2006.16.164.

  PMID: 16646710 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

MeSH Terms

Conditions

Pectus Carinatum; Motor Activity

Interventions

Exercise

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; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mustafa Yuksel, Prof

  Marmara University

  STUDY CHAIR

• Gulseren Akyuz, Prof

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessor blinded to participants' allocated group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group randomized controlled study

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: June 18, 2018
• Study Start: July 1, 2018
• Primary Completion: December 2, 2018
• Study Completion: December 2, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-07

Locations

TU (1)