Morgan Stanley Children's Hospital of NewYork-PresbyterianColumbia Orthopaedics Pediatric Orthopaedic Surgery
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Studies Open for Enrollment

 

Prospective Study of Deformity Management and Pulmonary Function in Early Onset Scoliosis

 


Purpose

Recent advances in the understanding of the role of spinal growth retardation, including iatrogenic growth retardation by conventional spinal fusion, in the development of thoracic insufficiency syndrome have produced a new concept of treatment, that of expansion thoracoplasty. This method allows direct volume expansion of the thorax by an “opening wedge” thoracostomy.

A second advance in management of early onset spinal deformity is through a stable double rod construct.  This two-rod technique appears to have reduced technical complications of earlier single rod methods dramatically, rekindling interest in this method as an alternative to conventional arthrodesis in young patients who have failed or are unable to be managed orthotically.

There is need for clarification of the indications and efficacy of these innovative procedures to manage early onset spinal deformities, which currently are performed based on subjective indications. A prospective study is proposed to determine efficacy of spinal deformity management combined with efficacy of pulmonary function management.

With this study, we try to concomitantly document the control of spinal deformity achieved with both  treatment methods, the growth of the thoracic spine longitudinally and transversely at a rate commensurate with the amount of involvement, and increasing lung volume, absolute and relative to body size, documented by serial volume and function determinations.

Who are Eligible?

Patients with a spinal deformity onset under age 8 and a diagnosis of idiopathic or idiopathic-like scoliosis, and patients with idiopathic-like deformity secondary to other non-neurologic etiologies (e.g. thoracogenic, cardiogenic scoliosis).

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Study Procedures/Recruitment

Eligible patients and their caregivers will be asked if they are willing to participate in this study. After obtaining informed consent, they will be enrolled into the study at the point of contact by the consulting pediatric orthopaedic surgeon and/or a study coordinator. This initial visit with the surgeon will only involve patient enrollment into the study. Once informed consent has been obtained at this visit, patients and their caregivers will be asked to come back for their study related visits. These include a preoperative evaluation and four postoperative evaluations (immediate postop, 6 months, 1 year, 2 years after surgery). Eventually, the patient has to be followed, as a standard of care procedure, annually.

What happens at each of the study visits?

Whenever the patient comes for his therapy visits, the research team will ask the parents to complete a short set of questionnaires regarding their children’s condition.

The time needed to complete all study questionnaires at each study time point is approximately 20 minutes.

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