Idiopathic ScoliosisNCT01019109
Scoliosis Surgery Using the PASS® LP System
An observational study of Idiopathic Scoliosis, run by Medicrea, USA Corp. at 3 sites in United States.
Trial summary
The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the spine that is caused by scoliosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgeon's Practice/Clinic
Who may be able to join
- Idiopathic scoliosis requiring posterior spinal instrumentation and fusion
- Male and female
Who cannot join
- Neuromuscular or degenerative scoliosis
- Spinal cord abnormalities with any neurologic symptoms or signs
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
- Primary muscle diseases, such as muscular dystrophy
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, Neurofibroma)
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
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- Congenital scoliosis
- Scoliosis requiring anterior release
- Previous spinal surgery
- Patient who is unable to complete a self-administered patient questionnaire
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Nationwide Children's Hospital
Columbus, Ohio, 43205
LSU Health Sciences Center
New Orleans, Louisiana, 70112
About this study
Official title: Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.
The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the spine that is caused by scoliosis. Also, this study wants to find out the effects this system has on the physical appearance and quality of life for patients with scoliosis.
Read the detailed description
The aim of this study is to evaluate the clinical, functional and radiographic outcomes following the reduction of idiopathic scoliosis.
The following will be evaluated
- The 3D correction of scoliosis:
- Reduction of scoliosis in the coronal plane (Cobb angles)
- Correction in the sagittal plane (kyphotic and lordotic angles)
- Correction of the axial vertebral rotation in the transverse plane
- The functional and aesthetic outcomes
- Conditions
- Idiopathic Scoliosis
- Being tested
- Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.
- Keywords
- scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.Device
Also called PASS® LP Spinal System, Low Profile Polyaxial Spine System, Pedicular Screw System
PASS LP Implant System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine only. These implants are designed to stabilize the spine during normal development of solid bony consolidation which takes about 18 months. The internal fixation devices are composed of screws, hooks,rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients.
| Study group | Role | What they receive |
|---|---|---|
| Titanium rod | Titanium rods used as a part of PSF construct Receives: Device: Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct. | |
| CoCr Rod | Cobalt Chrome rods used as a part of PSF construct Receives: Device: Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes
Measured: Preoperative, 6 weeks, 6 months, 1 year and 2 Years
Secondary outcomes (2)
Functional and aesthetic outcomes
Measured: Preoperative, 6 months and 2 years
Perioperative and postoperative complications
Measured: Continuous during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startMay 2010
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicrea, USA Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Devito, M.D., Principal investigator, Children's Healthcare of Atlanta, GAAndrew King, M.D., Principal investigator, LSU Health Sciences Center-New Orleans, LAMark Willits, M.D., Principal investigator, Nationwide Children's Hospital- Columbus, OHAfshin Aminian, MD, Principal investigator, Chilren's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019109
- Sponsor's protocol ID
- #0305
- Status last verified
- Mar 2018
- First submitted
- 20 Nov 2009
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.
- ClinicalTrials.gov ID
- NCT01019109
- Acronym / sponsor ID
- #0305
- Conditions
- Idiopathic Scoliosis
- Keywords
- scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Medicrea, USA Corp.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Nov 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.
The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the spine that is caused by scoliosis. Also, this study wants to find out the effects this system has on the physical appearance and quality of life for patients with scoliosis.
Detailed description
The aim of this study is to evaluate the clinical, functional and radiographic outcomes following the reduction of idiopathic scoliosis.
The following will be evaluated
- The 3D correction of scoliosis:
- Reduction of scoliosis in the coronal plane (Cobb angles)
- Correction in the sagittal plane (kyphotic and lordotic angles)
- Correction of the axial vertebral rotation in the transverse plane
- The functional and aesthetic outcomes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium rod | – | Device: Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.Titanium rods used as a part of PSF construct |
| CoCr Rod | – | Device: Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.Cobalt Chrome rods used as a part of PSF construct |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgeon's Practice/Clinic
Key inclusion criteria (2 listed)
- Idiopathic scoliosis requiring posterior spinal instrumentation and fusion
- Male and female
Key exclusion criteria (10 listed)
- Neuromuscular or degenerative scoliosis
- Spinal cord abnormalities with any neurologic symptoms or signs
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
- Primary muscle diseases, such as muscular dystrophy
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, Neurofibroma)
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 |
|---|---|---|
| Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.Also: PASS® LP Spinal System, Low Profile Polyaxial Spine System, Pedicular Screw SystemPASS LP Implant System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine only. These implants are designed to stabilize the spine during normal development of solid bony consolidation which takes about 18 months. The internal fixation devices are composed of screws, hooks,rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients. | Device | CoCr Rod, Titanium rod |
Primary outcome
Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes
Time frame: Preoperative, 6 weeks, 6 months, 1 year and 2 Years
2 secondary outcomes
Functional and aesthetic outcomes
Time frame: Preoperative, 6 months and 2 years
Perioperative and postoperative complications
Time frame: Continuous during follow-up
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 21 Mar 2018.
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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.
Dennis Devito, M.D. principal investigator
Children's Healthcare of Atlanta, GA
Andrew King, M.D. principal investigator
LSU Health Sciences Center-New Orleans, LA
Mark Willits, M.D. principal investigator
Nationwide Children's Hospital- Columbus, OH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis, run by Medicrea, USA Corp. at 3 sites in United States.
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 2 inclusion and 10 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 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
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?
Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes (time frame: Preoperative, 6 weeks, 6 months, 1 year and 2 Years). 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 Mar 2018.