Juvenile and Adolescent Idiopathic ScoliosisAISNCT05631821
3-D Correction of Adolescent Idiopathic Scoliosis (AIS) With Differential Metals
A study testing differential rod bending with rod contours (MESA Spinal System) in people with Juvenile and Adolescent Idiopathic Scoliosis, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study is designed to evaluate the coronal, sagittal, and axial correction of deformity secondary to adolescent idiopathic scoliosis utilizing a technique employing a posterior spinal fusion construct utilizing rods of different material rigidity and asymmetric bends determined using computer-based software to… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile and Adolescent Idiopathic Scoliosis
- What is being tested?
- differential rod bending with rod contours (MESA Spinal System)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2022
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of adolescent idiopathic scoliosis. Qualified patients will be confirmed for inclusion by patient history and radiographic studies
- Lenke Classification Curve type 1, 2, or 3.
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent
- Skeletally mature (Risser grade III or higher, closed tri-radiate cartilage) between the ages of 10 and 18 years of age
Who cannot join
- Previous spine surgery
- Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine
- Active systemic infection or infection at the operative site
- Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
- Metabolic bone disease such as osteoporosis and osteopenia that contraindicates spinal surgery
- History of an osteoporotic fracture
Show all 19Show fewer
- History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
- Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
- Known allergy to titanium or cobalt chrome
- Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C, or fibromyalgia
- Insulin-dependent type 1 or type 2 diabetes
- Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
- Pregnant, or intends to become pregnant, during the course of the study
- Severe obesity (Body Mass Index > 40)
- Physical or mental condition (e.g., psychiatric disorder, dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain, or quality of life.
- Involved in current or pending spinal litigation where permanent disability benefits are being sought
- Incarcerated at the time of study enrollment
- Current participation in an investigational study that may impact study outcomes
- Lenke Classification Curve Type 4, 5, or 6.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Three-axis Correction of Spinal Deformity and Post-implantation Rod Contour Changes Utilizing Differential Rod Bending and Pre-operative Templating in Adolescent Idiopathic Scoliosis: A Pilot Study
This study is designed to evaluate the coronal, sagittal, and axial correction of deformity secondary to adolescent idiopathic scoliosis utilizing a technique employing a posterior spinal fusion construct utilizing rods of different material rigidity and asymmetric bends determined using computer-based software to pre-operatively template a best-fit rod contour from pre-operative radiographs. To further evaluate the changes in contour of the rods from the pre-operative templates to the post-implantation radiographs.
Read the detailed description
Current posterior instrumentation devices employ pedicle screw and hook based systems to correct spinal deformity. Challenges remain for surgeons to appropriately contour the rods used to achieve the desired correction. The current practice is for the surgeon to intra-operatively contour the rod using various bending tools based on the appearance of the spine. The surgeon visually estimates the amount of bend needed and contours the rod accordingly. Changes in rod contours during implantation from the forces of correction limit the ability to achieve desired and optimal corrections. This is possibly related to both inaccurate bending estimates as well as techniques that affect the peri-implantation rod contours. These phenomena may lead to complications including but not limited to failure of hardware, coronal and/or sagittal spinal imbalance, and adjacent segment pathology or failure. The ability for the surgeon to pre-operatively calculate the proper bends to generate a predictable correction may improve patient outcomes by achieving better overall correction, better coronal and sagittal balance, reduce adjacent segment pathology.The purpose of this study is to evaluate the correction of adolescent idiopathic scoliosis deformity achieved utilizing a technique of differential rod bending with rod contours pre-operatively determined from a best-fit measure utilizing a computer-based software tool,Surgimap Spine to generate a template for manual rod contouring. The study will correlate the post-operative changes in rod contours with the correction achieved in spinal deformity. The pilot study will be used to validate the model for a prospective, randomized, multi-center, study of statistical power to compare the results of pre-operatively determined rod contours to intra-operatively determined rod contours
- Being tested
- differential rod bending with rod contours (MESA Spinal System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
differential rod bending with rod contours (MESA Spinal System)Procedure or surgery
Also called MESA Spinal System
differential rod bending with rod contours and Mesa Spinal system evaluate the correction of adolescent idiopathic scoliosis deformity achieved utilizing a technique of differential rod bending with rod contours pre-operatively determined from a best-fit measure utilizing a computer-based software tool
| Study group | Role | What they receive |
|---|---|---|
| Prospective Range Spinal System | Active comparator | Adolescent (between the ages of 10-18 years of age), with Idiopathic Scoliosis Range Spinal System: rod contour changes utilizing Differential Rod Bending and pre-operative templating in Adolescent Idiopathic Scoliosis: A pilot study. The prospective arm consented subjects will use the Rod Counour measurement system Receives: Procedure: differential rod bending with rod contours (MESA Spinal System) |
| Retrospective | No intervention | Retrospective matched cohort of subjects from the investigating surgeon are subjects that have not used the Rod contour measurement system. There is no intervention because the second arm is retrospective chart review. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-op and Post-op Standing Coronal Spinal Xrays
Standard Radiographic Cobb Measurements in degrees in Coronal view
Measured: 24 months
Secondary outcomes (1)
Pre-op and Post-op Standing Sagittal Spinal Xrays
Standard Radiographic Cobb Measurements in degrees in Sagittal view
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study startOct 2014
- Primary completionNov 2022
- Study completionNov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Juvenile and Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Twenty (20) patients prospective and Twenty (20) retrospective. Retrospective matched cohort of patients from the investigating surgeon. The patients will have had surgery using rods but without the MESA™ Spinal Fixation System. The prospective patient will have surgery using rods with the MESA™ Spinal Fixation System.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VB Spine, LLC
- Responsible party
- Principal investigator, Christopher J DeWald, Rush University Medical Center
- Investigators
- Christopher J DeWald, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631821
- Sponsor's protocol ID
- AIS Pilot Study
- Acronym
- AIS
- Status last verified
- Nov 2022
- First submitted
- 18 May 2015
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cidambi KR, Glaser DA, Bastrom TP, Nunn TN, Ono T, Newton PO. Postoperative changes in spinal rod contour in adolescent idiopathic scoliosis: an in vivo deformation study. Spine (Phila Pa 1976). 2012 Aug 15;37(18):1566-72. doi: 10.1097/BRS.0b013e318252ccbe.
PubMed 22426445Luk KD, Vidyadhara S, Lu DS, Wong YW, Cheung WY, Cheung KM. Coupling between sagittal and frontal plane deformity correction in idiopathic thoracic scoliosis and its relationship with postoperative sagittal alignment. Spine (Phila Pa 1976). 2010 May 15;35(11):1158-64. doi: 10.1097/BRS.0b013e3181bb49f3.
PubMed 20118836
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-axis Correction of Spinal Deformity and Post-implantation Rod Contour Changes Utilizing Differential Rod Bending and Pre-operative Templating in Adolescent Idiopathic Scoliosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT05631821
- Acronym / sponsor ID
- AIS / AIS Pilot Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- VB Spine, LLC
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 30 Nov 2022 (actual)
- 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 study is designed to evaluate the coronal, sagittal, and axial correction of deformity secondary to adolescent idiopathic scoliosis utilizing a technique employing a posterior spinal fusion construct utilizing rods of different material rigidity and asymmetric bends determined using computer-based software to pre-operatively template a best-fit rod contour from pre-operative radiographs. To further evaluate the changes in contour of the rods from the pre-operative templates to the post-implantation radiographs.
Detailed description
Current posterior instrumentation devices employ pedicle screw and hook based systems to correct spinal deformity. Challenges remain for surgeons to appropriately contour the rods used to achieve the desired correction. The current practice is for the surgeon to intra-operatively contour the rod using various bending tools based on the appearance of the spine. The surgeon visually estimates the amount of bend needed and contours the rod accordingly. Changes in rod contours during implantation from the forces of correction limit the ability to achieve desired and optimal corrections. This is possibly related to both inaccurate bending estimates as well as techniques that affect the peri-implantation rod contours. These phenomena may lead to complications including but not limited to failure of hardware, coronal and/or sagittal spinal imbalance, and adjacent segment pathology or failure. The ability for the surgeon to pre-operatively calculate the proper bends to generate a predictable correction may improve patient outcomes by achieving better overall correction, better coronal and sagittal balance, reduce adjacent segment pathology.The purpose of this study is to evaluate the correction of adolescent idiopathic scoliosis deformity achieved utilizing a technique of differential rod bending with rod contours pre-operatively determined from a best-fit measure utilizing a computer-based software tool,Surgimap Spine to generate a template for manual rod contouring. The study will correlate the post-operative changes in rod contours with the correction achieved in spinal deformity. The pilot study will be used to validate the model for a prospective, randomized, multi-center, study of statistical power to compare the results of pre-operatively determined rod contours to intra-operatively determined rod contours
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Twenty (20) patients prospective and Twenty (20) retrospective. Retrospective matched cohort of patients from the investigating surgeon. The patients will have had surgery using rods but without the MESA™ Spinal Fixation System. The prospective patient will have surgery using rods with the MESA™ Spinal Fixation System.
| Arm | Type | Receives |
|---|---|---|
| Prospective Range Spinal System | Active comparator | Procedure: differential rod bending with rod contours (MESA Spinal System)Adolescent (between the ages of 10-18 years of age), with Idiopathic Scoliosis Range Spinal System: rod contour changes utilizing Differential Rod Bending and pre-operative templating in Adolescent Idiopathic Scoliosis: A pilot study. The prospective arm consented subjects will use the Rod Counour measurement system |
| Retrospective | No intervention | –Retrospective matched cohort of subjects from the investigating surgeon are subjects that have not used the Rod contour measurement system. There is no intervention because the second arm is retrospective chart review. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of adolescent idiopathic scoliosis. Qualified patients will be confirmed for inclusion by patient history and radiographic studies
- Lenke Classification Curve type 1, 2, or 3.
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent
- Skeletally mature (Risser grade III or higher, closed tri-radiate cartilage) between the ages of 10 and 18 years of age
Key exclusion criteria (19 listed)
- Previous spine surgery
- Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine
- Active systemic infection or infection at the operative site
- Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
- Metabolic bone disease such as osteoporosis and osteopenia that contraindicates spinal 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 |
|---|---|---|
| differential rod bending with rod contours (MESA Spinal System)Also: MESA Spinal Systemdifferential rod bending with rod contours and Mesa Spinal system evaluate the correction of adolescent idiopathic scoliosis deformity achieved utilizing a technique of differential rod bending with rod contours pre-operatively determined from a best-fit measure utilizing a computer-based software tool | Procedure or surgery | Prospective Range Spinal System |
Primary outcome
Pre-op and Post-op Standing Coronal Spinal Xrays
Time frame: 24 months
Standard Radiographic Cobb Measurements in degrees in Coronal view
1 secondary outcome
Pre-op and Post-op Standing Sagittal Spinal Xrays
Time frame: 24 months
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 2 Dec 2022.
- Results publication: PubMed 22426445Cidambi KR, Glaser DA, Bastrom TP, Nunn TN, Ono T, Newton PO. Postoperative changes in spinal rod contour in adolescent idiopathic scoliosis: an in vivo deformation study. Spine (Phila Pa 1976). 2012 Aug 15;37(18):1566-72. doi: 10.1097/BRS.0b013e318252ccbe.
- Results publication: PubMed 20118836Luk KD, Vidyadhara S, Lu DS, Wong YW, Cheung WY, Cheung KM. Coupling between sagittal and frontal plane deformity correction in idiopathic thoracic scoliosis and its relationship with postoperative sagittal alignment. Spine (Phila Pa 1976). 2010 May 15;35(11):1158-64. doi: 10.1097/BRS.0b013e3181bb49f3.
- Individual participant dataSharing planned: No
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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.
Christopher J DeWald, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing differential rod bending with rod contours (MESA Spinal System) in people with Juvenile and Adolescent Idiopathic Scoliosis, run by Rush University Medical Center at 1 site 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 5 inclusion and 19 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 2 Dec 2022. 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 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?
Pre-op and Post-op Standing Coronal Spinal Xrays (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05631821, which also lists 2 linked publications.
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 2 Dec 2022.