Min Implants Max Outcomes Clinical Trial

Completed · Not applicable

Conditions studied: Scoliosis, Adolescent Idiopathic Scoliosis

In brief

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.

Key facts

Study ID

NCT01792609

Run by

University of Minnesota

People needed

200

Starts

2013-04-18

Expected to finish

2019-06-01

Last updated by the study team

2022-08-03

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.