Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy (PCPS)
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| ClinicalTrials.gov Identifier: NCT00680264 |
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Recruitment Status :
Recruiting
First Posted : May 20, 2008
Last Update Posted : April 28, 2022
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Sponsor:
Setting Scoliosis Straight Foundation
Collaborator:
K2M, Inc.
Information provided by (Responsible Party):
Setting Scoliosis Straight Foundation
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Brief Summary:
The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis surgical and non-operative treatment in patients with Cerebral Palsy.
| Condition or disease |
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| Cerebral Palsy Scoliosis |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 402 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy |
| Study Start Date : | June 2008 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
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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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Primary Outcome Measures :
- radiographic outcomes [ Time Frame: 5 year ]
Secondary Outcome Measures :
- Clinical outcomes [ Time Frame: 5 years ]
- Health related quality of life outcomes [ Time Frame: 5 years ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 8 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study
Criteria
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680264
Contacts
| Contact: Michelle C. Marks, PT, MA | 619-810-1430 | mmarks@ssshsg.org |
Locations
| United States, California | |
| Rady Children's Hospital | Recruiting |
| San Diego, California, United States, 92123 | |
| 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: Petya Yorgova 302-651-6518 pyorgova@nemours.org | |
| Principal Investigator: Suken Shah, MD | |
| United States, Florida | |
| Miami Children's Hospital | Recruiting |
| Miami, Florida, United States, 33155 | |
| Principal Investigator: Tom Errico, MD | |
| United States, Maryland | |
| Johns Hopkins Medical Institute | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Principal Investigator: Paul Sponseller, MD | |
| United States, Massachusetts | |
| Boston Children's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Mike Glotzbecker, MD | |
| United States, New York | |
| New York University Hospital for Joint Diseases | Recruiting |
| New York, New York, United States, 10003 | |
| Principal Investigator: Tom Errico, MD | |
| Columbia University | Recruiting |
| New York, New York, United States, 10034 | |
| Principal Investigator: Michael Vitale, MD | |
| Sub-Investigator: Ben Roye, MD | |
| United States, Ohio | |
| Cincinnati Children's Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Principal Investigator: Peter Sturm, MD | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: Jack Flynn, MD | |
| Sub-Investigator: Pat Cahill, MD | |
| Shriners Hospital for Children | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140-4131 | |
| Sub-Investigator: Amer Samdani, MD | |
| United States, Texas | |
| Texas Scottish Rite Hospital | Recruiting |
| Dallas, Texas, United States, 75219 | |
| Principal Investigator: Dan Sucato, MD | |
| Sub-Investigator: Brandon Ramos, MD | |
| Sub-Investigator: Amy McIntosh, MD | |
| United States, Virginia | |
| Kluge Children's Rehab. Ctr. | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Principal Investigator: Mark Abel, MD | |
| Sub-Investigator: Keith Bachmann, MD | |
| Canada | |
| CHU Saint-Justine Hospital | Recruiting |
| Montreal, Canada | |
| Contact: Marjolaine Roy-Beaudry marjolaine.beaudry@recherche-ste-justine.qc.ca | |
| Contact: Isabelle Turgeon isabelle.turgeon@recherche-ste-justine.qc.ca | |
| Principal Investigator: Hubert Labelle, MD | |
| Sub-Investigator: Stefan Parent, MD | |
| Hospital for Sick Children | Recruiting |
| Toronto, Canada | |
| Principal Investigator: Unni G Narayanan, MBBS | |
| British Columbia Children's Hospital | Recruiting |
| Vancouver, Canada | |
| Principal Investigator: Chris Reilly, MD | |
| Sub-Investigator: Firoz Miyanji, MD | |
Sponsors and Collaborators
Setting Scoliosis Straight Foundation
K2M, Inc.
Investigators
| 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 |
Additional Information:
| Responsible Party: | Setting Scoliosis Straight Foundation |
| ClinicalTrials.gov Identifier: | NCT00680264 |
| Other Study ID Numbers: |
2007HSG021 |
| First Posted: | May 20, 2008 Key Record Dates |
| Last Update Posted: | April 28, 2022 |
| Last Verified: | April 2022 |
Keywords provided by Setting Scoliosis Straight Foundation:
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Treatment Outcomes Scoliosis Cerebral Palsy |
Additional relevant MeSH terms:
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Scoliosis Paralysis Cerebral Palsy Neurologic Manifestations Nervous System Diseases Brain Damage, Chronic |
Brain Diseases Central Nervous System Diseases Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases |