Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03548922
Status:
UNKNOWN
Last Update Posted:
2018-07-03
First Post:
2018-05-20
Brief Title:
Impact of Risser Stage on Pressure of Correction in Pectus Carinatum
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Impact of Risser Stage on Pressure of Correction in Pectus Carinatum
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 It can be responsible of physical signs and symptoms and also has significant psychological impact The classical management of pectus deformities both carinatum and excavatum has been primarily surgical Modification of the Ravitch technique involves resection of the deformed costal cartilages along with sternal osteotomy Because the results of this technique resulted in worse cosmetic results a new less invasive procedure the Nuss procedure was developed Nuss procedure includes remodeling of the chest wall cartilage with an internal support bar These techniques have demonstrated the plasticity of the chest wall and led clinicians to hypothesize that carinatum defects would also remodel in response to chronic pressure leading to a cosmetically superior nonoperative technique compression brace Compression brace is a dynamic orthosis which is custom-fitted rigid aluminum brace that is adjustable to any thoracic shape Complications of brace use include uncommon 46 mild and easy to resolve back pain hematoma and skin ulceration Pressure of correction is the pressure applied to the patient in the most protruding area of the chest needed to accomplish a proper shape of the thorax It is an indirect parameter of the chest walls flexibility It can be measured with a pressure measuring device in pounds per square inches PSI Some special designed braces contain a part in which pressure measuring device can be docked This enables measuring of pressure of treatment Pressure of treatment can be different from pressure of correction since skin breakdown occurs with corrections at high pressure
In the Calgary protocol wearing brace 23 hours a day during the correction phase until the development of the axial skeleton is completed and afterwards 8 hours of wear is recommended in the continuation phase Marcelo Martinez-Ferro et al developed pressure measuring device and special designed braces contain a part in which pressure measuring device can be docked They suggested that patients with pressure of correction 10 should be braced De Beer et al also recommended the surgical treatment in the presence of chondro-manubrial type PC and pressure of correction 10 PSI
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 Marcelo 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
In general the long bone growth plates close at 15 to 17 years in males and 13 to 15 years of age in females An accurate way to determine the skeletal age of a child is to use an X ray of the left wrist and to compare it with X rays in the Greulich and Pyle atlas Here a series of X rays showing the development and ossification of the wrist and hand bones is displayed together with the average age these appear The axial skeleton matures a few years later than the limbs and for scoliosis the Risser sign is a useful method of bone age determination Skeletal age can be determined by the appearance of the iliac apophysis of the pelvis The apophysis appears laterally on a pelvic X ray and moves towards the spine as the patient approaches adulthood Rissers sign is a measure the growth left in the spine - this may help to determine the potential for progression of scoliosis
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 Demographic data age sex pressure of correction Tanner stage Risser stage Haller index pectus carinatum protrusion measurements of patients with PC will be recorded and association of them with pressure of correction will be investigated
In the Calgary protocol wearing brace 23 hours a day during the correction phase until the development of the axial skeleton is completed and afterwards 8 hours of wear is recommended in the continuation phase Marcelo Martinez-Ferro et al developed pressure measuring device and special designed braces contain a part in which pressure measuring device can be docked They suggested that patients with pressure of correction 10 should be braced De Beer et al also recommended the surgical treatment in the presence of chondro-manubrial type PC and pressure of correction 10 PSI
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 Marcelo 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
In general the long bone growth plates close at 15 to 17 years in males and 13 to 15 years of age in females An accurate way to determine the skeletal age of a child is to use an X ray of the left wrist and to compare it with X rays in the Greulich and Pyle atlas Here a series of X rays showing the development and ossification of the wrist and hand bones is displayed together with the average age these appear The axial skeleton matures a few years later than the limbs and for scoliosis the Risser sign is a useful method of bone age determination Skeletal age can be determined by the appearance of the iliac apophysis of the pelvis The apophysis appears laterally on a pelvic X ray and moves towards the spine as the patient approaches adulthood Rissers sign is a measure the growth left in the spine - this may help to determine the potential for progression of scoliosis
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 Demographic data age sex pressure of correction Tanner stage Risser stage Haller index pectus carinatum protrusion measurements of patients with PC will be recorded and association of them with pressure of correction will be investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None