Impact of Risser Stage on Pressure of Correction in Pectus Carinatum

July 1, 2018 updated by: Marmara University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with pectus carinatum who never experienced brace before

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Day 0
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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Chair: Mustafa Yuksel, Prof, Marmara University
  • Study Director: Gulseren Akyuz, Prof, Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 20, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 7, 2018

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

July 1, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2018.327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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