Status:
COMPLETED
Min Implants Max Outcomes Clinical Trial
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Alfred I. duPont Hospital for Children
Texas Scottish Rite Hospital for Children
Conditions:
Scoliosis
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10-18 years
Phase:
NA
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 cont...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01792609
Start Date
April 18 2013
End Date
June 1 2019
Last Update
August 3 2022
Active Locations (14)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Nemours/ Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
3
Children's Research Institute
Washington D.C., District of Columbia, United States, 20010-2916
4
University of Florida
Gainesville, Florida, United States, 32611