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| Sponsors and Collaborators: |
Children's Specialists Foundation DePuy Spine |
|---|---|
| Information provided by: | Children's Specialists Foundation |
| ClinicalTrials.gov Identifier: | NCT00680264 |
Purpose
The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis surgical treatment in patients with Cerebral Palsy.
| Condition |
|---|
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Cerebral Palsy Scoliosis |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Prospective Study of Scoliosis in Children With Cerebral Palsy |
| Estimated Enrollment: | 402 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2012 |
| Groups/Cohorts |
|---|
|
Operative
Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level Curve >40 degrees on sitting film, A spinal fusion is being undertaken and the patient/family is proceeding with the spinal fusion (with any level of distal fusion).
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Non-operative
Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level, Curve >40 degrees on sitting film, A spinal fusion is not being undertaken either because the family has refused surgery or because it is not recommended at this point.
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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.
Eligibility| Ages Eligible for Study: | 8 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michelle C. Marks, PT, MA | 520-529-2546 | mmarks@comcast.net |
| United States, California | |
| Rady Children's Hospital | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Molly Moor, BS 858-576-1700 ext 3181 mmoor@rchsd.org | |
| Principal Investigator: Peter Newton, MD | |
| Sub-Investigator: Burt Yaszay, MD | |
| United States, Delaware | |
| A.I. Dupont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19803 | |
| Contact: Geraldine Neiss, PhD 302-651-6518 gneiss@nemours.org | |
| Principal Investigator: Suken Shah, MD | |
| United States, Florida | |
| Miami Children's Hospital | Not yet recruiting |
| Miami, Florida, United States, 33155 | |
| Contact: Dianna Morales, MD 305-662-8346 dianna.morales@mch.com | |
| Sub-Investigator: Harry Shufflebarger, MD | |
| Principal Investigator: Mike O'Brien, MD | |
| United States, Maryland | |
| John's Hopkins Medical Institute | Recruiting |
| Baltimore, Maryland, United States, 21287-0882 | |
| Contact: Kristen Venuti, RN 410-955-4798 kvenuti@jhmi.edu | |
| Principal Investigator: Paul Sponseller, MD | |
| United States, Pennsylvania | |
| Shriners Hospital for Children | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140-4131 | |
| Contact: Lisa Merenda, RN 215-430-4190 lmerenda@shrinenet.org | |
| Sub-Investigator: Randal Betz, MD | |
| Sub-Investigator: Amer Samdani, MD | |
| Principal Investigator: Patrick Cahill, MD | |
| Sub-Investigator: David Clements, MD | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Nina Agrawal 215-590-1522 agrawaln@emial.chop.edu | |
| Principal Investigator: Jack Flynn, MD | |
| United States, Texas | |
| Texas Scottish Rite Hospital | Recruiting |
| Dallas, Texas, United States, 75219 | |
| Contact: Anna McClung, RN 214-559-7685 anna.mcclung@tsrh.org | |
| Principal Investigator: Dan Sucato, MD | |
| United States, Virginia | |
| Kluge Children's Rehab. Ctr. | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Karen Johnson, RN 434-924-5983 KMS4C@hscmail.mcc.virginia.edu | |
| Principal Investigator: Mark Abel, MD | |
| Canada | |
| British Columbia Children's Hospital | Not yet recruiting |
| Vancouver, Canada | |
| Contact: Caitlin Blewitt, BS 604-875-2359 CBlewett@cw.bc.ca | |
| Principal Investigator: Chris Reilly, MD | |
| Sub-Investigator: Firoz Miyanji, MD | |
| Germany | |
| Rehabilitationskrankenhaus Lagensteinbach | Not yet recruiting |
| Karlsbad-Lagensteinbach, Germany | |
| Contact: Lynn 011-49-7202-61-3347 lynn.letko@kkl.srh.de | |
| Principal Investigator: Lynn Letko, MD | |
| Principal Investigator: | Paul Sponseller, MD | John's Hopkins Hospital |
| Study Director: | Peter Newton, MD | Rady Children's Hospital San Deigo |
| Study Chair: | Michelle Marks, PT, MA | Harms Study Group |
More Information
| Responsible Party: | Children's Specialists Foundation ( Peter Newton, MD - Director of Harms Study Group ) |
| Study ID Numbers: | 1-08-1847 |
| Study First Received: | May 16, 2008 |
| Last Updated: | August 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00680264 |
| Health Authority: | United States: Institutional Review Board |
|
Treatment Outcomes Scoliosis Cerebral Palsy |
|
Spinal Diseases Paralysis Scoliosis Cerebral Palsy Musculoskeletal Diseases |
Brain Damage, Chronic Central Nervous System Diseases Brain Diseases Brain Injuries Bone Diseases |
|
Spinal Curvatures Nervous System Diseases |
