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Pectus CarinatumNCT03548922

Impact of Risser Stage on Pressure of Correction in Pectus Carinatum

An observational study of Pectus Carinatum, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 22 yearsHealthy volunteers can take part
Conditions the study is for
Pectus Carinatum
What is being tested?
Tanner stage, Risser stage and Pressure of correction
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2018to 1 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 22 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Patients with pectus carinatum who never experienced brace before

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Esra Giray, MD contact

05558134394

girayesra@hotmail.com

Onur Ermenak, Asist Prof contact

+905337141463

noermerak@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

    Istanbul, 34899

    Giray Esra, MD, +905558134394, girayesra@hotmail.com

    MD

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Tanner stage, Risser stage, Pressure of correction, Pectus carinatum protrusion
Keywords
Risser, Tanner, pressure of correction
Medical subject headings
Pectus Carinatum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tanner stageOther

    a scale of pubertal development in children, adolescents

  • Risser stageOther

    a measure showing the growth left in the spine

  • Pressure of correctionOther

    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 protrusionOther

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

Study groups in NCT03548922
Study groupRoleWhat they receive
Pectus carinatumDemographic 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.
Receives: Other: Tanner stage; Other: Risser stage; Other: Pressure of correction; Other: Pectus carinatum protrusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risser (a measure showing the growth left in the spine)

    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

    Measured: Day 0

Secondary outcomes (3)
  1. Tanner (a scale of physical pubertal development in children, adolescents and adults)

    a scale of physical pubertal development in children, adolescents and adults.

    Measured: Day 0

  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)

    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.

    Measured: Day 0

  3. Pectus carinatum protrusion (distance from the point of maximum protrusion to the estimated normal level of chest wall)

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

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2018
  2. Study start1 Jul 2018
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion1 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03548922
Sponsor's protocol ID
09.2018.327
Status last verified
Jul 2018
First submitted
20 May 2018
Last updated
3 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19632563
  • 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.

    PubMed 29078485
  • 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.

    PubMed 16677884
  • 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.

    PubMed 28274516
  • 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.

    PubMed 23331813
  • Kang DY, Jung J, Chung S, Cho J, Lee S. Factors affecting patient compliance with compressive brace therapy for pectus carinatum. Interact Cardiovasc Thorac Surg. 2014 Dec;19(6):900-3. doi: 10.1093/icvts/ivu280. Epub 2014 Aug 27.

    PubMed 25164133
  • http://www0.sun.ac.za/ortho/webct-ortho/age/risser.html -].

Questions about this trial

What is this clinical trial studying?

An observational study of Pectus Carinatum, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Esra Giray, MD (05558134394, girayesra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risser (a measure showing the growth left in the spine) (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03548922, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.

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