Cerebral PalsyNCT02547090
Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Phoenix Children's Hospital.
Trial summary
Background: Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of complications and mortality. Complication rates have been reported as high as 45%, and infection rates typically reported at 15%. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- The use of two attending surgeons during posterior spinal fusion
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Mar 2015
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study group consisted of 25 consecutive patients with CP and progressive neuromuscular scoliosis who underwent PSF in 2012 with the use of a two surgeon team. The control group consisted of a consecutive series of patients with CP who underwent PSF by a single surgeon from 2008-2010 at the same institution. The control group was a cohort of patients matched for age, gender, weight and Cobb angle.
Who may be able to join
- Cerebral palsy
- neuromuscular scoliosis requiring posterior spinal fusion (>50 degree Cobb)
- PSF from 2008-2012 at Phoenix Children's Hospital
- GMFCS IV or V
Who cannot join
- Diagnosis other than CP
- GMFCS I-III
- Previous spine deformity surgery
About this study
Official title: The Effect of Two Surgeons on Blood Loss and Operative Time in Cerebral Palsy (CP) Patients Undergoing Posterior Spinal Fusion
Background:
Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of complications and mortality. Complication rates have been reported as high as 45%, and infection rates typically reported at 15%. Efforts to improve efficiency by reducing operative time and blood loss could decrease these risks. The purpose of this study is to investigate the impact of utilizing two attending surgeons on blood loss, operative time, and complications in this population.
Read more
Methods:
This is a prospective, matched cohort analysis with a consecutive series of patients with CP who underwent PSF, with two attending surgeons, in 2012. These are matched with a control group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA, or RN-FA. The groups are compared using paired Student T-tests and chi square tests (significance set a p<0.05).
- Conditions
- Cerebral Palsy
- Being tested
- The use of two attending surgeons during posterior spinal fusion
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The use of two attending surgeons during posterior spinal fusionProcedure or surgery
Patients in the experimental group received posterior spinal fusion with two attending surgeons. Patients in the control group received posterior spinal fusion with one attending surgeon and one first assist, which could be a resident, PA, or nurse.
| Study group | Role | What they receive |
|---|---|---|
| CP who underwent PSF by two attendings in 2012 | Not described Receives: Procedure: The use of two attending surgeons during posterior spinal fusion | |
| CP who underwent PSF by a single surgeon from 2008-2010 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications due to PFS surgery
Measured: Post-operative hospital stay (up to 12 days)
Secondary outcomes (3)
Surgical time
Measured: intraoperative
Estimated blood loss
Measured: intraoperative
Length of Stay
Measured: During hospitalization (up to 12 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startFeb 2012
- Primary completionMay 2014
- Study completionMar 2015
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547090
- Sponsor's protocol ID
- 11-124
- Status last verified
- Sep 2015
- First submitted
- 9 Sep 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Surgeons on Blood Loss and Operative Time in Cerebral Palsy (CP) Patients Undergoing Posterior Spinal Fusion
- ClinicalTrials.gov ID
- NCT02547090
- Acronym / sponsor ID
- 11-124
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Sep 2015 (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.
Background:
Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of complications and mortality. Complication rates have been reported as high as 45%, and infection rates typically reported at 15%. Efforts to improve efficiency by reducing operative time and blood loss could decrease these risks. The purpose of this study is to investigate the impact of utilizing two attending surgeons on blood loss, operative time, and complications in this population.
Methods:
This is a prospective, matched cohort analysis with a consecutive series of patients with CP who underwent PSF, with two attending surgeons, in 2012. These are matched with a control group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA, or RN-FA. The groups are compared using paired Student T-tests and chi square tests (significance set a p<0.05).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP who underwent PSF by two attendings in 2012 | – | Procedure: The use of two attending surgeons during posterior spinal fusion |
| CP who underwent PSF by a single surgeon from 2008-2010 | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study group consisted of 25 consecutive patients with CP and progressive neuromuscular scoliosis who underwent PSF in 2012 with the use of a two surgeon team. The control group consisted of a consecutive series of patients with CP who underwent PSF by a single surgeon from 2008-2010 at the same institution. The control group was a cohort of patients matched for age, gender, weight and Cobb angle.
Key inclusion criteria (4 listed)
- Cerebral palsy
- neuromuscular scoliosis requiring posterior spinal fusion (>50 degree Cobb)
- PSF from 2008-2012 at Phoenix Children's Hospital
- GMFCS IV or V
Key exclusion criteria (3 listed)
- Diagnosis other than CP
- GMFCS I-III
- Previous spine deformity surgery
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 |
|---|---|---|
| The use of two attending surgeons during posterior spinal fusionPatients in the experimental group received posterior spinal fusion with two attending surgeons. Patients in the control group received posterior spinal fusion with one attending surgeon and one first assist, which could be a resident, PA, or nurse. | Procedure or surgery | CP who underwent PSF by two attendings in 2012 |
Primary outcome
Complications due to PFS surgery
Time frame: Post-operative hospital stay (up to 12 days)
3 secondary outcomes
Surgical time
Time frame: intraoperative
Estimated blood loss
Time frame: intraoperative
Length of Stay
Time frame: During hospitalization (up to 12 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Phoenix Children's Hospital.
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 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: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complications due to PFS surgery (time frame: Post-operative hospital stay (up to 12 days)). 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 11 Sep 2015.