Min Implants Max Outcomes Clinical Trial

Not Applicable

Completed

• Conditions: Scoliosis; Adolescent Idiopathic Scoliosis
• Interventions: Procedure: Maximum Number of Screws; Procedure: Minimum Number of Screws

• Registration Number: NCT01792609
• Lead Sponsor: University of Minnesota

Brief Summary

Objectives Primary objective: Determine if there is a clinically significant difference in percent Cobb curve correction in a low- vs. high-implant density cohort through a prospective randomized controlled trial.

Design and Outcomes Randomized clinical trial of equivalence to test the efficacy and safety of low vs. high implant density instrumentation for spine deformity surgery in AIS patients with Lenke IA curve patterns.

Interventions and Duration Intervention: low-implant density group or high-implant density group. Duration: 2 years. Sample Size and Population Target population: 10 to 17 years old with AIS who will undergo instrumented spinal fusion. Sample size needed (power = 90%) is 174 subjects with 87 in each group.

Detailed Description

The MIMO Study Group proposes to conduct a prospective randomized controlled trial in order to determine whether a low implant density cohort has equivalent clinical and radiographic results to a high implant density cohort. This study is proposed as a trial of equivalence. The null hypothesis is that significant differences exist in percent major Cobb angle correction between high- and low-implant density cohorts for Lenke 1A curve types, the most common scoliotic curve pattern (73). Consecutive qualifying patients will be screened and enrolled by high-volume spine surgeons at 14 sites and randomized to spinal instrumentation with a low- or high-density screw pattern. Patients will return at 3-months, 1-year, and 2-years for exam, radiographs, and collection of patient-reported outcome scores. The Harms Study Group Foundation will serve as a collaborating organization and will provide database development and management, secure online data collection, centralized radiographic measurements, and data quality control. The University of Minnesota team will lead study design, protocol development, IRB/data use agreement contracts, patient randomization, and statistical analysis, including quarterly data review. Imaging will be obtained either with an EOS system or using a calibration belt during the radiographs, which allows for subsequent with the 3D modeling of the deformity. Six enrolling sites currently have this capability (EOS - Montreal, St. Louis, Iowa, Mayo, DuPont, and San Diego). An additional five sites already have calibration belts - Dallas, New York, Baltimore, Boston, U. of Rochester), and new calibration belts will be fabricated for the additional sites. The Montreal site will supervise collection of radiographic data with 3D capability and assist with troubleshooting and radiographic quality control. Although the study is primarily powered to detect change in percent correction of the major coronal curve, preliminary data will be gathered on axial and sagittal plane correction as well as complications, surgical factors, and patient-reported outcomes.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Study Start: 2013-04-18
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients aged ≥10 and ≤ 18 years
• Male or Female
• Diagnosis of idiopathic scoliosis for which surgery is recommended to prevent the curvature or to correct trunk disfigurement Lenke 1A curve pattern
• Curve cobb of 45° to 65°
• T5-T12 kyphosis measuring 0° to 40°
• Spina bifida Oculta is permitted
• Spondylolisthesis and Spondylolysis are permitted, as long as non- operative

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Exclusion Criteria

• Prior spinal surgery
• MRI abnormalities (including >4mm of Syrinx and/or Chiari malformation)
• Neuromuscular or other serious co-morbidities
• Thoracogenic or cardiogenic scoliosis
• Associated syndrome or developmental delay
• Unable or unwilling to firmly commit to returning for required follow-up

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maximum Number of Screws	Maximum Number of Screws	Once enrolled and consented, patients with Lenke 1A curves will be randomized to a high- or low-density screw cohort. The high-density pattern will be designated as ≥ 1.8 implants per level fused. The low density pattern will be ≤ 1.4 screws per level fused. At least 75% of the implants must be pedicle screws for both cohorts.
Minimum Number of Screws	Minimum Number of Screws	Once enrolled and consented, patients with Lenke 1A curves will be randomized to a high- or low-density screw cohort. The high-density pattern will be designated as ≥ 1.8 implants per level fused. The low density pattern will be ≤ 1.4 screws per level fused. At least 75% of the implants must be pedicle screws for both cohorts.

Primary Outcome Measures

Name	Time	Method
Change in Cobb Angle	pre-surgery ranging 1 year to 1 month and peri surgery at about 3-months, 1-year, and 2-year postoperative	Radiographic, surgical, and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with 3D analysis capability, either with a calibration belt using standard radiograph techniques or with an EOS imaging system. This will allow for additional detailed correction measures, such as change in spinal rotation (orientation of the planes of maximum curvature) and detailed coronal, sagittal and transverse plane measures. Bending films will be taken according to institutional protocol. The SRS-30, SAQ, and EQ5D will be collected at all clinical visits. Study questions will be aligned as much as possible with other prospective scoliosis protocols so as to minimize patient and surgeon response burden. The study protocol requires no additional visits or radiographs beyond standard of care.

Secondary Outcome Measures

Name	Time	Method
3D parameter correction	collected during surgical procedure	Surgeon reported measure of screw manipulation during the surgery.
Blood Loss	During surgery, 1 time occurence	Blood loss amount that occured during the surgical procedure.
Operative Time	1 time measurement, occurs at surgery	Length of time required to complete surgical procedure in either arm of the study (highest number or lowest number of screws).

Trial Locations

Locations (14)

The Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Centre Hospitalier Universitaire Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada

Nemours/ Alfred I. duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

Children's Research Institute; 🇺🇸 Washington, District of Columbia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Texas Scottish Rite Hospital for Children; 🇺🇸 Dallas, Texas, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Norton Leatherman Spine Center; 🇺🇸 Louisville, Kentucky, United States