Min Implants Max Outcomes Clinical Trial (MIMOCT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01792609 |
Recruitment Status :
Completed
First Posted : February 15, 2013
Last Update Posted : November 1, 2019
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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 |
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Scoliosis Adolescent Idiopathic Scoliosis | Procedure: Maximum Number of Screws Procedure: Minimum Number of Screws | Not Applicable |
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 |
Actual Study Start Date : | January 2013 |
Actual Primary Completion Date : | June 1, 2019 |
Actual Study Completion Date : | June 1, 2019 |

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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.
- Blood Loss [ Time Frame: During surgery, 1 time occurence ]Blood loss amount that occured during the surgical procedure.
- 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).
- 3D parameter correction [ Time Frame: collected during surgical procedure ]Surgeon reported measure of screw manipulation during the surgery.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | David W Polly, MD | University of Minnesota |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT01792609 |
Other Study ID Numbers: |
1208M18202 |
First Posted: | February 15, 2013 Key Record Dates |
Last Update Posted: | November 1, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Scoliosis Cobb Angle Screw Density Outcomes Measures |
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases |