Min Implants Max Outcomes Clinical Trial

Scoliosis Clinical Trial

— MIMOCT  

Official title:

Minimize Implants Maximize Outcomes (MIMO) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792609
• Other study ID #: 1208M18202
• Status: Completed
• Phase: N/A
• Start date: April 18, 2013
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire Sainte-Justine	Montreal	Quebec
United States	Emory University	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	Texas Scottish Rite Hospital for Children	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	University of Iowa	Iowa City	Iowa
United States	Norton Leatherman Spine Center	Louisville	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	The Washington University in St. Louis	Saint Louis	Missouri
United States	Children's Research Institute	Washington	District of Columbia
United States	Nemours/ Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (12)

Lead Sponsor	Collaborator
University of Minnesota	Alfred I. duPont Hospital for Children, Children's Hospital Colorado, Children's Hospital of Philadelphia, Johns Hopkins University, Mayo Clinic, Norton Leatherman Spine Center, St. Justine's Hospital, Texas Scottish Rite Hospital for Children, University of Iowa, University of Rochester, Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood Loss	Blood loss amount that occured during the surgical procedure.	During surgery, 1 time occurence
Secondary	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
Secondary	3D parameter correction	Surgeon reported measure of screw manipulation during the surgery.	collected during surgical procedure