Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy (PCPS)

November 20, 2023 updated by: Setting Scoliosis Straight Foundation
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

402

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michelle C. Marks, PT, MA
  • Phone Number: 619-810-1430
  • Email: mmarks@ssshsg.org

Study Locations

  • Canada
      • Montreal, Canada
      • Toronto, Canada
        • Recruiting
        • Hospital for Sick Children
        • Principal Investigator:
          • Unni G Narayanan, MBBS
      • Vancouver, Canada
        • Recruiting
        • British Columbia Children's Hospital
        • Sub-Investigator:
          • Firoz Miyanji, MD
        • Principal Investigator:
          • Chris Reilly, MD
  • United States
    • California
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital
        • Principal Investigator:
          • Peter Newton, MD
        • Sub-Investigator:
          • Burt Yaszay, MD
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • A.I. Dupont Hospital for Children
        • Principal Investigator:
          • Suken Shah, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33155
        • Recruiting
        • Miami Children's Hospital
        • Principal Investigator:
          • Tom Errico, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medical Institute
        • Principal Investigator:
          • Paul Sponseller, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Principal Investigator:
          • Mike Glotzbecker, MD
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • New York University Hospital for Joint Diseases
        • Principal Investigator:
          • Tom Errico, MD
      • New York, New York, United States, 10034
        • Recruiting
        • Columbia University
        • Principal Investigator:
          • Michael Vitale, MD
        • Sub-Investigator:
          • Ben Roye, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
        • Principal Investigator:
          • Peter Sturm, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Principal Investigator:
          • Jack Flynn, MD
        • Sub-Investigator:
          • Pat Cahill, MD
      • Philadelphia, Pennsylvania, United States, 19140-4131
        • Recruiting
        • Shriners Hospital for Children
        • Sub-Investigator:
          • Amer Samdani, MD
    • Texas
      • Dallas, Texas, United States, 75219
        • Recruiting
        • Texas Scottish Rite Hospital
        • Sub-Investigator:
          • Amy McIntosh, MD
        • Principal Investigator:
          • Dan Sucato, MD
        • Sub-Investigator:
          • Brandon Ramos, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • Kluge Children's Rehab. Ctr.
        • Principal Investigator:
          • Mark Abel, MD
        • Sub-Investigator:
          • Keith Bachmann, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (Child, Adult)

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
radiographic outcomes
Time Frame: 5 year
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical outcomes
Time Frame: 5 years
5 years
Health related quality of life outcomes
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Setting Scoliosis Straight Foundation

Collaborators

K2M, Inc.

Investigators

  • Study Director: Peter Newton, MD, Rady Children's Hospital San Deigo
  • Principal Investigator: Paul Sponseller, MD, John's Hopkins Hospital
  • Study Chair: Michelle Marks, PT, MA, Harms Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimated)

May 20, 2008

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007HSG021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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