Recruiting

Observational StudyProspective Database Registry Study of Scoliosis in Children With Cerebral Palsy

Sponsor:

Setting Scoliosis Straight Foundation

Code:

NCT00680264

Conditions

Cerebral Palsy

Scoliosis

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cerebral Palsy

Scoliosis

Study ID

NCT00680264

Start date

Jun, 2008

Status verified date

Nov, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

402 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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.

Primary outcome measure

radiographic outcomes [ Time Frame: 5 year ]

Central Contacts and Locations

Central contacts

Michelle C. Marks, PT, MA

619-810-1430 mmarks@ssshsg.org

Locations

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Principal Investigator:

Peter Newton, MD

A.I. Dupont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Petya Yorgova

302-651-6518 pyorgova@nemours.org

Principal Investigator:

Suken Shah, MD

Miami Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Principal Investigator:

Tom Errico, MD

Johns Hopkins Medical Institute

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Paul Sponseller, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Mike Glotzbecker, MD

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

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Principal Investigator:

Peter Sturm, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Jack Flynn, MD

Shriners Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19140-4131

Texas Scottish Rite Hospital

Recruiting

Dallas, Texas, United States, 75219

Principal Investigator:

Dan Sucato, MD

Kluge Children's Rehab. Ctr.

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

Mark Abel, MD

CHU Saint-Justine Hospital

Recruiting

Montreal, Canada

Contacts

Marjolaine Roy-Beaudry

marjolaine.beaudry@recherche-ste-justine.qc.ca

Isabelle Turgeon

isabelle.turgeon@recherche-ste-justine.qc.ca

Principal Investigator:

Hubert Labelle, 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

More Information

Sponsor

Setting Scoliosis Straight Foundation

Last update posted

Nov 21, 2023

Last verified

Nov, 2023

Keywords

Treatment Outcomes
Scoliosis
Cerebral Palsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Setting Scoliosis Straight Foundation on 2023-11-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.