Prospective Study of Scoliosis in Children With Cerebral Palsy (PCPS)
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Purpose
The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis surgical treatment in patients with Cerebral Palsy.
| Condition |
|---|
|
Cerebral Palsy Scoliosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Prospective Study of Scoliosis in Children With Cerebral Palsy |
- radiographic outcomes [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
- Clinical outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Health related quality of life outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 402 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2015 |
| 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.
|
Detailed Description:
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 21 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:
- 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)
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: JoAnna Roocroft, BS 858-576-1700 ext 3186 jroocroft@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 | 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: Kim Costello, RN 215-430-4248 kcostello@shrinenet.org | |
| Sub-Investigator: Randal Betz, MD | |
| Sub-Investigator: Amer Samdani, MD | |
| Principal Investigator: Patrick Cahill, MD | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Stephanie Cody 215-590-1522 codys@email.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: Lindsay Sauer 434-924-5983 LKD4D@hscmail.mcc.virginia.edu | |
| Principal Investigator: Mark Abel, MD | |
| Canada | |
| British Columbia Children's Hospital | Recruiting |
| Vancouver, Canada | |
| Contact: Veronika Scheepmaker 604-875-2359 VScheepmaker@cw.bc.ca | |
| Principal Investigator: Chris Reilly, MD | |
| Sub-Investigator: Firoz Miyanji, MD | |
| Germany | |
| Rehabilitationskrankenhaus Lagensteinbach | 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
No publications provided
| Responsible Party: | Setting Scoliosis Straight Foundation |
| ClinicalTrials.gov Identifier: | NCT00680264 History of Changes |
| Other Study ID Numbers: | 2007HSG021 |
| Study First Received: | May 16, 2008 |
| Last Updated: | July 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Setting Scoliosis Straight Foundation:
|
Treatment Outcomes Scoliosis Cerebral Palsy |
Additional relevant MeSH terms:
|
Cerebral Palsy Paralysis Brain Damage, Chronic Brain Diseases Scoliosis Central Nervous System Diseases Nervous System Diseases |
Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013