MIMO Clinical Trial

This study is currently recruiting participants.
Verified July 2013 by University of Minnesota - Clinical and Translational Science Institute
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
Hospital St. Justine
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01792609
First received: January 22, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Scoliosis
Adolescent Idiopathic Scoliosis
Procedure: Maximum Number of Screws
Procedure: Minimum Number of Screws
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minimize Implants Maximize Outcomes (MIMO) Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Blood Loss [ Time Frame: During surgery, 1 time occurence ] [ Designated as safety issue: Yes ]
    Blood loss amount that occured during the surgical procedure.

  • Operative Time [ Time Frame: 1 time measurement, occurs at surgery ] [ Designated as safety issue: No ]
    Length of time required to complete surgical procedure in either arm of the study (highest number or lowest number of screws).

  • 3D parameter correction [ Time Frame: collected during surgical procedure ] [ Designated as safety issue: No ]
    Surgeon reported measure of screw manipulation during the surgery.


Estimated Enrollment: 174
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, Medtronic Product Code: NKB, OSH, KWP, KWQ, MNH, MNI.
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, Medtronic Product Code: NKB, OSH, KWP, KWQ, MNH, MNI.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged ≥10 and ≤ 17 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792609

Contacts
Contact: David W Polly, MD 612-273-7983 pollydw@umn.edu
Contact: Ivana Ninkovic, MPH, MS 612-273-8082 nink0002@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Ivana Ninkovic, MPH, MS    612-273-8082    nink0002@umn.edu   
Contact: David W Polly, MD    612-273-7983    pollydw@umn.edu   
Principal Investigator: David W Polly, MD         
Sub-Investigator: Charles G Ledonio, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Contact: Noelle A Larson, MD    507-244-0093    Larson.Noelle@mayo.edu   
Principal Investigator: Noelle A Larson, MD         
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
Hospital St. Justine
Investigators
Principal Investigator: David Polly, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01792609     History of Changes
Other Study ID Numbers: MIMO1208M18202
Study First Received: January 22, 2013
Last Updated: July 16, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014