Clinical trial NCT01792609: Min Implants Max Outcomes Clinical Trial
Official title: Minimize Implants Maximize Outcomes (MIMO) Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
Cobb Angle
Screw Density
Outcomes Measures
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Alfred I. duPont Hospital for Children
name: Texas Scottish Rite Hospital for Children
name: Johns Hopkins University
name: University of Rochester
name: Washington University School of Medicine
name: Children's Hospital Colorado
name: Mayo Clinic
name: University of Iowa
name: Norton Leatherman Spine Center
name: Children's Hospital of Philadelphia
name: St. Justine's Hospital
First posted: 2013-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Cobb Angle
timeFrame: pre-surgery ranging 1 year to 1 month and peri surgery at about 3-months, 1-year, and 2-year postoperative
Secondary outcomes:
measure: Blood Loss
timeFrame: During surgery, 1 time occurence
measure: Operative Time
timeFrame: 1 time measurement, occurs at surgery
measure: 3D parameter correction
timeFrame: collected during surgical procedure
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Nemours/ Alfred I. duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's Research Institute
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: The Washington University in St. Louis
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Dallas
country: United States
facility: Texas Scottish Rite Hospital for Children
state: Texas
city: Montreal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine
state: Quebec
Study officials:
affiliation: University of Minnesota
name: David W Polly, MD
role: PRINCIPAL_INVESTIGATOR
References: