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Impact of Risser Stage on Pressure of Correction in Pectus Carinatum

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ClinicalTrials.gov Identifier: NCT03548922
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Marmara University

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.

Condition or disease Intervention/treatment
Pectus Carinatum Other: Tanner stage Other: Risser stage Other: Pressure of correction Other: Pectus carinatum protrusion

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Risser Stage on Pressure of Correction in Pectus Carinatum
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
a scale of pubertal development in children, adolescents

Other: Risser stage
a measure showing the growth left in the spine

Other: 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.

Other: Pectus carinatum protrusion
distance from the point of maximum protrusion to the estimated normal level of chest wall




Primary Outcome Measures :
  1. Risser (a measure showing the growth left in the spine) [ Time Frame: Day 0 ]
    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


Secondary Outcome Measures :
  1. Tanner (a scale of physical pubertal development in children, adolescents and adults) [ Time Frame: Day 0 ]
    a scale of physical pubertal development in children, adolescents and adults.

  2. 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) [ Time Frame: Day 0 ]
    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.

  3. Pectus carinatum protrusion (distance from the point of maximum protrusion to the estimated normal level of chest wall) [ Time Frame: Day 0 ]
    distance from the point of maximum protrusion to the estimated normal level of chest wall



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Ages Eligible for Study:   5 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with pectus carinatum who never experienced brace before
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548922


Contacts
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Contact: Esra Giray, MD 05558134394 girayesra@hotmail.com
Contact: Onur Ermenak, Asist Prof +905337141463 noermerak@hotmail.com

Locations
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Turkey
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Recruiting
Istanbul, Turkey, 34899
Contact: Giray Esra, MD    +905558134394    girayesra@hotmail.com   
Contact: , MD         
Sponsors and Collaborators
Marmara University
Investigators
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Study Chair: Mustafa Yuksel, Prof Marmara University
Study Director: Gulseren Akyuz, Prof Marmara University
Principal Investigator: Esra Giray, MD Marmara University

Publications:
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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03548922     History of Changes
Other Study ID Numbers: 09.2018.327
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marmara University:
Risser
Tanner
pressure of correction

Additional relevant MeSH terms:
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Pectus Carinatum
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases