Min Implants Max Outcomes Clinical Trial (MIMOCT)

Minimize Implants Maximize Outcomes (MIMO) Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Procedure: Maximum Number of Screws; Procedure: Minimum Number of Screws

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1C5
      • Centre Hospitalier Universitaire Sainte-Justine
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours/ Alfred I. duPont Hospital for Children
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-2916
      • Children's Research Institute
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Leatherman Spine Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • The Washington University in St. Louis
  • New York
    • Rochester, New York, United States, 14618
      • University of Rochester
  • Texas
    • Dallas, Texas, United States, 75219
      • Texas Scottish Rite Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Maximum Number of Screws; The tools used for this arm of study are FDA approved with section 510 (k) K122433. These screws are regularly used in all procedures pertaining to Cobb angle correction surgeries outside of the context of this study.; Other Names: Pedicle Screw Spinal System
Active Comparator: 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.	Procedure: Minimum Number of Screws; The tools used for this arm of study are FDA approved with section 510 (k) K122433. These screws are regularly used in all procedures pertaining to Cobb angle correction surgeries outside of the context of this study.; Other Names: Pedicle Screw Spinal System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cobb Angle	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.	pre-surgery ranging 1 year to 1 month and peri surgery at about 3-months, 1-year, and 2-year postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Johns Hopkins University; Mayo Clinic; Children's Hospital of Philadelphia; Washington University School of Medicine; University of Iowa; Children's Hospital Colorado; University of Rochester; St. Justine's Hospital; Alfred I. duPont Hospital for Children; Texas Scottish Rite Hospital for Children; Norton Leatherman Spine Center
• Investigators: Principal Investigator: David W Polly, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2013
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: February 13, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Scoliosis; Cobb Angle; Screw Density; Outcomes Measures
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 1208M18202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No