Journal article
The Effect of Implant Density on Adolescent Idiopathic Scoliosis Fusion: Results of the Minimize Implants Maximize Outcomes Randomized Clinical Trial
Journal of bone and joint surgery. American volume, Vol.106(3), pp.180-189
02/07/2024
DOI: 10.2106/JBJS.23.00178
Abstract
BACKGROUND Severe adolescent idiopathic scoliosis (AIS) can be treated with instrumented fusion, but the number of anchors needed for optimal correction is controversial. METHODS We conducted a multicenter, randomized study that included patients undergoing spinal fusion for single thoracic curves between 45° and 65°, the most common form of operatively treated AIS. Of the 211 patients randomized, 108 were assigned to a high-density screw pattern and 103, to a low-density screw pattern. Surgeons were instructed to use ≥1.8 implants per spinal level fused for patients in the high-implant-density group or ≤1.4 implants per spinal level fused for patients in the low-implant-density group. The primary outcome measure was the percent correction of the coronal curve at the 2-year follow-up. The power analysis for this trial required 174 patients to show equivalence, defined as a 95% confidence interval (CI) within a ±10% correction margin with a probability of 90%.RESULTS In the intention-to-treat analysis, the mean percent correction of the coronal curve was equivalent between the high-density and low-density groups at the 2-year follow-up (67.6% versus 65.7%; difference, -1.9% [95% CI: -6.1%, 2.2%]). In the per-protocol cohorts, the mean percent correction of the coronal curve was also equivalent between the 2 groups at the 2-year follow-up (65.0% versus 66.1%; difference, 1.1% [95% CI: -3.0%, 5.2%]). A total of 6 patients in the low-density group and 5 patients in the high-density group required reoperation (p = 1.0).CONCLUSIONS In the setting of spinal fusion for primary thoracic AIS curves between 45° and 65°, the percent coronal curve correction obtained with use of a low-implant-density construct and that obtained with use of a high-implant-density construct were equivalent .LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Details
- Title: Subtitle
- The Effect of Implant Density on Adolescent Idiopathic Scoliosis Fusion: Results of the Minimize Implants Maximize Outcomes Randomized Clinical Trial
- Creators
- A Noelle Larson - Mayo ClinicDavid W Polly - University of MinnesotaPaul D Sponseller - Johns Hopkins UniversityMichael P Kelly - Rady Children's Hospital-San DiegoB Stephens Richards - Texas Scottish Rite Hospital for ChildrenSumeet Garg - Children's Hospital ColoradoStefan Parent - Centre Hospitalier Universitaire Sainte-JustineSuken A Shah - Dupont HospitalStuart L Weinstein - University of IowaCharles H CrawfordJames O Sanders - University of RochesterLaurel C Blakemore - University of FloridaMatthew E Oetgen - Children's NationalNicholas D Fletcher - Emory UniversityWalter K Kremers - Mayo Clinic in FloridaMichelle C Marks - Setting Scoliosis Straight FoundationAnn M Brearley - University of Minnesota SystemCarl-Eric AubinDaniel J Sucato - Texas Scottish Rite Hospital for ChildrenHubert Labelle - Centre Hospitalier Universitaire Sainte-JustineMark A Erickson - Children's Hospital Colorado
- Resource Type
- Journal article
- Publication Details
- Journal of bone and joint surgery. American volume, Vol.106(3), pp.180-189
- DOI
- 10.2106/JBJS.23.00178
- eISSN
- 1535-1386
- Language
- English
- Electronic publication date
- 11/16/2023
- Date published
- 02/07/2024
- Academic Unit
- Stead Family Department of Pediatrics; Orthopedics and Rehabilitation
- Record Identifier
- 9984513299202771
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