Min Implants Max Outcomes Clinical Trial (MIMOCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 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
St. Justine's Hospital
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01792609
First received: January 22, 2013
Last updated: May 13, 2016
Last verified: May 2016
  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
Scoliosis
Adolescent Idiopathic Scoliosis
Procedure: Maximum Number of Screws
Procedure: Minimum Number of Screws

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: 200
Study Start Date: January 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (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
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

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 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792609

Contacts
Contact: David W Polly, MD 612-273-7983 pollydw@umn.edu
Contact: Charles Ledonio, MD 612-273-8035 ledon001@umn.edu

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Nikki Bloch    720-777-5809    Nikki.Bloch@childrenscolorado.org   
Principal Investigator: Mark Erickson, MD         
United States, Delaware
Nemours/ Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Geraldine Neiss       Geraldine.Neiss@nemours.org   
Contact: Petya Yorgova       Petya.Yorgova@nemours.org   
Principal Investigator: Suken Shah, MD         
United States, District of Columbia
Children's Research Institute Recruiting
Washington, District of Columbia, United States, 20010-2916
Contact: Allison Matthews    202-476-4652    amatthew@childrensnational.org   
Principal Investigator: Matthew Oetgen, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Sarah Phillips, MPH, CPH    352-273-7343    phillsa@ortho.ufl.edu   
Principal Investigator: Laurel Blakemore, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Patricia Bush, Ed.D.    404-778-1563    patricia.a.bush@emory.edu   
Principal Investigator: Nicholas Fletcher, MD         
United States, Iowa
University of Iowa Recruiting
Iowa, Iowa, United States, 52242
Contact: Lori Dolan, PhD    319-356-1075    lori-dolan@uiowa.edu   
Principal Investigator: Stuart Weinstein, MD         
United States, Kentucky
Norton Leatherman Spine Center Recruiting
Louisville, Kentucky, United States, 40207
Contact: Kelly Bratcher, RN, CCRP    502-992-0488 ext 131    Kelly.bratcher2@nortonhealthcare.org   
Principal Investigator: Leah Carreon, MD, MSc         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Craig Remenapp, MS    410-502-6442    cremena1@jhmi.edu   
Principal Investigator: Paul Sponseller, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Charles Ledonio, MD    612-273-8035    ledon001@umn.edu   
Principal Investigator: David W Polly, MD         
Sub-Investigator: Charles G Ledonio, MD         
Principal Investigator: Noelle Larson, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Noelle A Larson, MD    507-244-0093    Larson.Noelle@mayo.edu   
Principal Investigator: Noelle A Larson, MD         
United States, Missouri
The Washington University in St. Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Brenda Sides, RN    314-747-2588    sidesb@wudosis.wustl.edu   
Principal Investigator: Munish Gupta, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14618
Contact: Krista Noble    585-341-9303    Krista_Noble@urmc.rochester.edu   
Principal Investigator: James Sanders, MD         
United States, Texas
Texas Scottish Rite Hospital for Children Recruiting
Dallas, Texas, United States, 75219
Contact: Kaitlyn Brown, BS    214-559-8547    Kaitlyn.Brown@tsrh.org   
Principal Investigator: B.Stephens Richards, MD         
Principal Investigator: Daniel Sucato, MD         
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Soraya Barchi    5143454931 ext 4352    soraya.barchi@umontreal.ca   
Principal Investigator: Hubert Labelle, 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
St. Justine's Hospital
Investigators
Principal Investigator: David W Polly, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

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: May 13, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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

ClinicalTrials.gov processed this record on July 27, 2016