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

NCT05631821 | Completed

• 1 other identifier: AIS Pilot Study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile and Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• Pre-op and Post-op Standing Coronal Spinal Xrays

  Standard Radiographic Cobb Measurements in degrees in Coronal view

  24 months

Secondary Outcomes (1)

• Pre-op and Post-op Standing Sagittal Spinal Xrays

  24 months

Study Arms (2)

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

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.

Interventions

differential rod bending with rod contours (MESA Spinal System) PROCEDURE

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

Also known as: MESA Spinal System

Prospective Range Spinal System

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Stryker Spine: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• 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.

  PMID: 22426445 RESULT

• 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.

  PMID: 20118836 RESULT

Study Officials

• Christopher J DeWald, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Spinal Deformity

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: November 30, 2022
• Study Start: October 1, 2014
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)