Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Risser Stage on Pressure of Correction in Pectus Carinatum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03548922
Recruitment Status : Unknown
Verified July 2018 by Marmara University.
Recruitment status was:  Recruiting
First Posted : June 7, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Marmara University

Tracking Information
First Submitted Date May 20, 2018
First Posted Date June 7, 2018
Last Update Posted Date July 3, 2018
Actual Study Start Date July 1, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 5, 2018)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Risser Stage on Pressure of Correction in Pectus Carinatum
Official Title Impact of Risser Stage on Pressure of Correction in Pectus Carinatum
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 (4.6%), 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 wall's 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. Risser's 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with pectus carinatum who never experienced brace before
Condition Pectus Carinatum
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Other: Tanner stage
  • Other: Risser stage
  • Other: Pressure of correction
  • Other: Pectus carinatum protrusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 5, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03548922
Other Study ID Numbers 09.2018.327
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marmara University
Study Sponsor Marmara University
Collaborators Not Provided
Investigators
Study Chair: Mustafa Yuksel, Prof Marmara University
Study Director: Gulseren Akyuz, Prof Marmara University
Principal Investigator: Esra Giray, MD Marmara University
PRS Account Marmara University
Verification Date July 2018