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3-D Correction of Adolescent Idiopathic Scoliosis (AIS) With Differential Metals (AIS)

Primary Purpose

Juvenile and Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
differential rod bending with rod contours (MESA Spinal System)
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile and Adolescent Idiopathic Scoliosis

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Prospective Range Spinal System

Retrospective

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Pre-op and Post-op Standing Coronal Spinal Xrays
Standard Radiographic Cobb Measurements in degrees in Coronal view

Secondary Outcome Measures

Pre-op and Post-op Standing Sagittal Spinal Xrays
Standard Radiographic Cobb Measurements in degrees in Sagittal view

Full Information

First Posted
May 18, 2015
Last Updated
November 29, 2022
Sponsor
Rush University Medical Center
Collaborators
Stryker Spine
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1. Study Identification

Unique Protocol Identification Number
NCT05631821
Brief Title
3-D Correction of Adolescent Idiopathic Scoliosis (AIS) With Differential Metals
Acronym
AIS
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
November 2022 (Actual)
Study Completion Date
November 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Stryker Spine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile and Adolescent Idiopathic Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective Range Spinal System
Arm Type
Active Comparator
Arm Description
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
Arm Title
Retrospective
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
differential rod bending with rod contours (MESA Spinal System)
Other Intervention Name(s)
MESA Spinal System
Intervention Description
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
Primary Outcome Measure Information:
Title
Pre-op and Post-op Standing Coronal Spinal Xrays
Description
Standard Radiographic Cobb Measurements in degrees in Coronal view
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Pre-op and Post-op Standing Sagittal Spinal Xrays
Description
Standard Radiographic Cobb Measurements in degrees in Sagittal view
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J DeWald, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22426445
Citation
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.
Results Reference
result
PubMed Identifier
20118836
Citation
Luk 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.
Results Reference
result

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3-D Correction of Adolescent Idiopathic Scoliosis (AIS) With Differential Metals

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