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Min Implants Max Outcomes Clinical Trial (MIMOCT)

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ClinicalTrials.gov Identifier: NCT01792609
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
Alfred I. duPont Hospital for Children
Texas Scottish Rite Hospital for Children
Johns Hopkins University
University of Rochester
Washington University School of Medicine
Children's Hospital Colorado
Mayo Clinic
University of Iowa
Norton Leatherman Spine Center
Children's Hospital of Philadelphia
St. Justine's Hospital
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.


Condition or disease Intervention/treatment Phase
Scoliosis Adolescent Idiopathic Scoliosis Procedure: Maximum Number of Screws Procedure: Minimum Number of Screws Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minimize Implants Maximize Outcomes (MIMO) Clinical Trial
Study Start Date : January 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis
U.S. FDA Resources

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 Name: 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 Name: Pedicle Screw Spinal System



Primary Outcome Measures :
  1. Change in Cobb Angle [ Time Frame: 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 :
  1. Blood Loss [ Time Frame: During surgery, 1 time occurence ]
    Blood loss amount that occured during the surgical procedure.

  2. Operative Time [ Time Frame: 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).

  3. 3D parameter correction [ Time Frame: collected during surgical procedure ]
    Surgeon reported measure of screw manipulation during the surgery.



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792609


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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01792609     History of Changes
Other Study ID Numbers: MIMO1208M18202
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Scoliosis
Cobb Angle
Screw Density
Outcomes Measures

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases