View Clinical Trial (Medical Research Study)
Prospective Study of Scoliosis in Children With Cerebral Palsy
| City: |
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Dallas |
| State: |
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Texas |
| Zip Code: |
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75219 |
| Conditions: |
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Cerebral Palsy - Scoliosis |
| Purpose: |
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The purpose of this study is to determine the radiographic and clinical outcomes of
Scoliosis surgical treatment in patients with Cerebral Palsy.
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| Study Summary: |
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Bracing severe neuromuscular scoliotic curves rarely serves as definitive treatment, thus
most progressive curves require surgical intervention in order to sustain or improve sitting
(or ambulatory) abilities. Surgery is a demanding intervention for these patients, with
variable functional gains. Controversy persists regarding indications for surgery, timing,
and technique. Concerns about complications are paramount. Previous neuromuscular studies
have been confined to a small number of surgeons with a narrow range of surgical
instrumentation, technique, and correction. Very little evidence exists regarding the
impact spinal surgery on the quality of life in children with scoliosis related to cerebral
palsy. The instruments to measure quality of life are not specific to children with
scoliosis related to cerebral palsy. There have been no comprehensive prospective studies
published. This study would be the first large-scale prospective, multi-center series of
spinal fusion outcomes in patients with Cerebral Palsy.
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| Criteria: |
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Inclusion Criteria:
- Patient age 8-21 years
- Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age
of 3) with total body involvement - any functional level
- Coronal Curve >50 degrees on sitting film (as measured by 'greatest Cobb') OR
Kyphotic curve >70 degrees on sitting film (as measured by T5-T12) AND
- A spinal fusion is being undertaken and the patient/family is proceeding with the
spinal fusion (with any level of distal fusion).
OR
• A spinal fusion is not being undertaken (Non-Operative cohort) either because the family
has refused surgery or because it is not recommended at this point or surgery is
recommended but is not being undertaken because they are on a waiting list, and are being
enrolled as a non-op patient because they will be on the waiting list for >18 months.
Exclusion Criteria:
- Previous operated scoliotic spine deformity
- Diagnosis of Rett's Syndrome
- Concomitant lower extremity surgery (within 3 months of spinal fusion)
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| NCT ID: |
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NCT00680264 |
| Primary Contact: |
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Principal Investigator
Paul Sponseller, MD
John's Hopkins Hospital
Michelle C. Marks, PT, MA
Phone: 520-529-2546
Email: mmarks@comcast.net
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| Backup Contact: |
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N/A |
| Location Contact: |
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Dallas, Texas 75219
United States
Anna McClung, RN
Phone: 214-559-7685
Email: anna.mcclung@tsrh.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
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