ScoliosisMIMOCTNCT01792609
Min Implants Max Outcomes Clinical Trial
A study testing Maximum Number of Screws and Minimum Number of Screws in people with Scoliosis and Adolescent Idiopathic Scoliosis, run by University of Minnesota at 14 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis, Adolescent Idiopathic Scoliosis
- What is being tested?
- Maximum Number of Screws and Minimum Number of Screws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 18 Apr 2013to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Emory University
Atlanta, Georgia, 30329
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21205
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75219
University of Florida
Gainesville, Florida, 32611
University of Iowa
Iowa City, Iowa, 52242
Norton Leatherman Spine Center
Louisville, Kentucky, 40207
University of Minnesota
Minneapolis, Minnesota, 55454
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14618
The Washington University in St. Louis
St Louis, Missouri, 63110
Children's Research Institute
Washington D.C., District of Columbia, 20010-2916
Nemours/ Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Canada1 site
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T1C5
About this study
Official title: Minimize Implants Maximize Outcomes (MIMO) Clinical Trial
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.
Read the 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.
- Conditions
- Scoliosis, Adolescent Idiopathic Scoliosis
- Being tested
- Maximum Number of Screws, Minimum Number of Screws
- Keywords
- Scoliosis, Cobb Angle, Screw Density, Outcomes Measures
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximum Number of ScrewsProcedure or surgery
Also called Pedicle Screw Spinal System
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 ScrewsProcedure or surgery
Also called Pedicle Screw Spinal System
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.
| Study group | Role | What they receive |
|---|---|---|
| Maximum Number of Screws | Active comparator | 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. Receives: Procedure: Maximum Number of Screws |
| Minimum Number of Screws | Active comparator | 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. Receives: Procedure: Minimum Number of Screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-surgery ranging 1 year to 1 month and peri surgery at about 3-months, 1-year, and 2-year postoperative
Secondary outcomes (3)
Blood Loss
Blood loss amount that occured during the surgical procedure.
Measured: During surgery, 1 time occurence
Operative Time
Length of time required to complete surgical procedure in either arm of the study (highest number or lowest number of screws).
Measured: 1 time measurement, occurs at surgery
3D parameter correction
Surgeon reported measure of screw manipulation during the surgery.
Measured: collected during surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start18 Apr 2013
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- David W Polly, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792609
- Sponsor's protocol ID
- 1208M18202
- Acronym
- MIMOCT
- Status last verified
- Aug 2022
- First submitted
- 22 Jan 2013
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimize Implants Maximize Outcomes (MIMO) Clinical Trial
- ClinicalTrials.gov ID
- NCT01792609
- Acronym / sponsor ID
- MIMOCT / 1208M18202
- Conditions
- Scoliosis, Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Cobb Angle, Screw Density, Outcomes Measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- 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
- Study start
- 18 Apr 2013 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximum Number of Screws | Active comparator | Procedure: Maximum Number of ScrewsOnce 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. |
| Minimum Number of Screws | Active comparator | Procedure: Minimum Number of ScrewsOnce 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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°
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximum Number of ScrewsAlso: Pedicle Screw Spinal SystemThe 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. | Procedure or surgery | Maximum Number of Screws |
| Minimum Number of ScrewsAlso: Pedicle Screw Spinal SystemThe 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. | Procedure or surgery | Minimum Number of Screws |
Primary outcome
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.
3 secondary outcomes
Blood Loss
Time frame: During surgery, 1 time occurence
Operative Time
Time frame: 1 time measurement, occurs at surgery
3D parameter correction
Time frame: collected during surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Polly, MD principal investigator
University of Minnesota
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximum Number of Screws and Minimum Number of Screws in people with Scoliosis and Adolescent Idiopathic Scoliosis, run by University of Minnesota at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.