Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2015-04-30

Brief Summary

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The objective of this study is to retrospectively and prospectively review patients who have undergone this technique looking at age of the patient, magnitude of the curve preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical procedures, complications, and spinal growth.

The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for natural growth of the spine in a guided fashion with a limited number of future surgeries required.

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Detailed Description

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Traditional "growing rod" constructs of spinal instrumentation to treat severe scoliosis in young children require a return to the operating room every six to nine months until skeletal maturity. The Shilla system allows for more spinal growth with fewer surgical procedures necessary for lengthenings. This is a major advantage over existing growth permitting systems and allows surgery to be performed at younger ages with better deformity correction without concerns of repeated surgeries.

Conditions

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Scoliosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1 Shilla Technique

The patients whose data is observed are those who have undergone the shilla surgical technique.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* between the ages of 1 yr and 10 yrs
* have severe, progressive scoliosis unresponsive to bracing
* have severe, progressive scoliosis who cannot tolerate bracing