Cerebral PalsyNCT00958542
Prospective Study of Cerebral Palsy Scoliosis
A study testing Surgical fusion in people with Cerebral Palsy and Scoliosis, run by University of British Columbia at 1 site in Canada.
Trial summary
This is a prospective, multi-centre study that will be looking at two groups of males and females over the course of their operative treatment for cerebral palsy (CP) scoliosis and the years following that treatment. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy, Scoliosis
- What is being tested?
- Surgical fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Jun 2017
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 8 and 18 years
- Diagnosis of Cerebral Palsy with total body involvement
- Coronal curve greater than 40 degrees OR a kyphotic curve greater than 50 degrees on sitting film will be included
- Growing rod treatment will also be included
Who cannot join
- Previous operated scoliotic spine deformity
- Diagnosis of Rett's Syndrome
- Concomitant lower extremity surgery (within 3 months of spinal fusion)
- Cornelia de Lange Syndrome or any pervasive genetic disorder whose effects are due to much more than the static cortical injury
- Ambulatory spastic diplegic without upper extremity impairment or speech, swallowing or other involvement
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Prospective Study of Scoliosis in Children With Cerebral Palsy
This is a prospective, multi-centre study that will be looking at two groups of males and females over the course of their operative treatment for cerebral palsy (CP) scoliosis and the years following that treatment. The first group the study will be looking at is those individuals who undergo surgery for CP Scoliosis. The second group will be those individuals who do not undergo surgical treatment for CP Scoliosis, either because the family declines surgery or surgery is not recommended during the course of study participation.
- Conditions
- Cerebral Palsy, Scoliosis
- Being tested
- Surgical fusion
- Keywords
- cerebral palsy, scoliosis, children
- 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.
Surgical fusionProcedure or surgery
Surgical intervention for correction of scoliotic or kyphotic curvatures of the spine will include either the posterior approach or the anterior + posterior approach, with either the unit or custom rod, depending on the choice of the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Arm | Experimental | Surgical intervention for correction of scoliotic or kyphotic curvatures of the spine will include either the posterior approach or the anterior + posterior approach, with either the unit or custom rod, depending on the choice of the surgeon. Receives: Procedure: Surgical fusion |
| Non-Surgical Arm | No intervention | Non-Surgical No intervention - Includes patients who have either refused to have surgery or have not been recommended to have surgery at this point. These patients will continue to be monitored closely, however, will not receive any other intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pre- and post- operative x-rays
Measured: 1 year
Secondary outcomes (1)
Gross motor function, physical data, past medical history, seizure status, pain and medications, sitting ability, activity level, clinical photos, quality of life questionnaires, data regarding surgery and hospital stay
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: This study is coordinated by the Harms Study Group. It is already registered on this website
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Firoz Miyanji, Dr., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958542
- Sponsor's protocol ID
- H08-00897
- Status last verified
- Jun 2014
- First submitted
- 11 Aug 2009
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Scoliosis in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00958542
- Acronym / sponsor ID
- H08-00897
- Conditions
- Cerebral Palsy, Scoliosis
- Keywords
- cerebral palsy, scoliosis, children
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: This study is coordinated by the Harms Study Group. It is already registered on this website
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 13 Aug 2009 (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.
This is a prospective, multi-centre study that will be looking at two groups of males and females over the course of their operative treatment for cerebral palsy (CP) scoliosis and the years following that treatment. The first group the study will be looking at is those individuals who undergo surgery for CP Scoliosis. The second group will be those individuals who do not undergo surgical treatment for CP Scoliosis, either because the family declines surgery or surgery is not recommended during the course of study participation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Arm | Experimental | Procedure: Surgical fusionSurgical intervention for correction of scoliotic or kyphotic curvatures of the spine will include either the posterior approach or the anterior + posterior approach, with either the unit or custom rod, depending on the choice of the surgeon. |
| Non-Surgical Arm | No intervention | –Non-Surgical No intervention - Includes patients who have either refused to have surgery or have not been recommended to have surgery at this point. These patients will continue to be monitored closely, however, will not receive any other intervention. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between the ages of 8 and 18 years
- Diagnosis of Cerebral Palsy with total body involvement
- Coronal curve greater than 40 degrees OR a kyphotic curve greater than 50 degrees on sitting film will be included
- Growing rod treatment will also be included
Key exclusion criteria (5 listed)
- Previous operated scoliotic spine deformity
- Diagnosis of Rett's Syndrome
- Concomitant lower extremity surgery (within 3 months of spinal fusion)
- Cornelia de Lange Syndrome or any pervasive genetic disorder whose effects are due to much more than the static cortical injury
- Ambulatory spastic diplegic without upper extremity impairment or speech, swallowing or other involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical fusionSurgical intervention for correction of scoliotic or kyphotic curvatures of the spine will include either the posterior approach or the anterior + posterior approach, with either the unit or custom rod, depending on the choice of the surgeon. | Procedure or surgery | Surgical Arm |
Primary outcome
Comparison of pre- and post- operative x-rays
Time frame: 1 year
1 secondary outcome
Gross motor function, physical data, past medical history, seizure status, pain and medications, sitting ability, activity level, clinical photos, quality of life questionnaires, data regarding surgery and hospital stay
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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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.
Firoz Miyanji, Dr. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical fusion in people with Cerebral Palsy and Scoliosis, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 5 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: paused, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pre- and post- operative x-rays (time frame: 1 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 23 Jun 2014.