Cerebral PalsyPCPSNCT00680264
Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Scoliosis, run by Setting Scoliosis Straight Foundation at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Cerebral Palsy, Scoliosis
- How many people
- 402 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Jun 2008to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study
Who may be able to join
- 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.
Who cannot join
- Previous operated scoliotic spine deformity
- Diagnosis of Rett's Syndrome
- Concomitant lower extremity surgery (within 3 months of spinal fusion)
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States12 sites, 12 recruiting
- Recruiting
Johns Hopkins Medical Institute
Baltimore, Maryland, 21287
Paul Sponseller, MD
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Mike Glotzbecker, MD
- Recruiting
Kluge Children's Rehab. Ctr.
Charlottesville, Virginia, 22908
Mark Abel, MD
Keith Bachmann, MD
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Peter Sturm, MD
- Recruiting
Texas Scottish Rite Hospital
Dallas, Texas, 75219
Dan Sucato, MD
Brandon Ramos, MD
- Recruiting
Miami Children's Hospital
Miami, Florida, 33155
Tom Errico, MD
- Recruiting
New York University Hospital for Joint Diseases
New York, New York, 10003
Tom Errico, MD
- Recruiting
Columbia University
New York, New York, 10034
Michael Vitale, MD
Ben Roye, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Jack Flynn, MD
Pat Cahill, MD
- Recruiting
Shriners Hospital for Children
Philadelphia, Pennsylvania, 19140-4131
Amer Samdani, MD
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Peter Newton, MD
Burt Yaszay, MD
- Recruiting
A.I. Dupont Hospital for Children
Wilmington, Delaware, 19803
Petya Yorgova, 302-651-6518, pyorgova@nemours.org
Suken Shah, MD
Canada3 sites, 3 recruiting
- Recruiting
CHU Saint-Justine Hospital
Montreal
Marjolaine Roy-Beaudry, marjolaine.beaudry@recherche-ste-justine.qc.ca
Isabelle Turgeon, isabelle.turgeon@recherche-ste-justine.qc.ca
- Recruiting
Hospital for Sick Children
Toronto
Unni G Narayanan, MBBS
- Recruiting
British Columbia Children's Hospital
Vancouver
Chris Reilly, MD
Firoz Miyanji, MD
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy, Scoliosis
- Keywords
- Treatment Outcomes, Scoliosis, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
radiographic outcomes
Measured: 5 year
Secondary outcomes (2)
Clinical outcomes
Measured: 5 years
Health related quality of life outcomes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Setting Scoliosis Straight Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- K2M, Inc.
- Responsible party
- Sponsor
- Investigators
- Paul Sponseller, MD, Principal investigator, John's Hopkins HospitalPeter Newton, MD, Study director, Rady Children's Hospital San DeigoMichelle Marks, PT, MA, Study chair, Harms Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680264
- Sponsor's protocol ID
- 2007HSG021
- Acronym
- PCPS
- Status last verified
- Nov 2023
- First submitted
- 16 May 2008
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00680264
- Acronym / sponsor ID
- PCPS / 2007HSG021
- Conditions
- Cerebral Palsy, Scoliosis
- Keywords
- Treatment Outcomes, Scoliosis, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Setting Scoliosis Straight FoundationUniversity, hospital or other
- Collaborators
- K2M, Inc.
- Study start
- Jun 2008
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Previous operated scoliotic spine deformity
- Diagnosis of Rett's Syndrome
- Concomitant lower extremity surgery (within 3 months of spinal fusion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
radiographic outcomes
Time frame: 5 year
2 secondary outcomes
Clinical outcomes
Time frame: 5 years
Health related quality of life outcomes
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Setting Scoliosis Straight Website - highlighting the research of the Harms Study GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Sponseller, MD principal investigator
John's Hopkins Hospital
Peter Newton, MD study director
Rady Children's Hospital San Deigo
Michelle Marks, PT, MA study chair
Harms Study Group
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Scoliosis, run by Setting Scoliosis Straight Foundation at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle C. Marks, PT, MA (619-810-1430, mmarks@ssshsg.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic outcomes (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.