The Effect of Implant Density on Adolescent Idiopathic Scoliosis Fusion

Author:

Larson A. Noelle1ORCID,Polly David W.2ORCID,Sponseller Paul D.3,Kelly Michael P.4ORCID,Richards B. Stephens5ORCID,Garg Sumeet6ORCID,Parent Stefan7ORCID,Shah Suken A.8,Weinstein Stuart L.9ORCID,Crawford Charles H.10ORCID,Sanders James O.11ORCID,Blakemore Laurel C.12ORCID,Oetgen Matthew E.13ORCID,Fletcher Nicholas D.14ORCID,Kremers Walter K.15ORCID,Marks Michelle C.16ORCID,Brearley Ann M.17ORCID,Aubin Carl-Eric18,Sucato Daniel J.5ORCID,Labelle Hubert7,Erickson Mark A.6,

Affiliation:

1. Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota

2. Department of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota

3. John Hopkins University, Baltimore, Maryland

4. Rady Children’s Hospital, San Diego, California

5. Texas Scottish Rite Hospital for Children, Dallas, Texas

6. Children’s Hospital of Colorado, Aurora, Colorado

7. St. Justine Hospital, Montreal, Quebec, Canada

8. Dupont Hospital, Fort Wayne, Indiana

9. University of Iowa, Iowa City, Iowa

10. Leatherman Spine, Louisville, Kentucky

11. University of Rochester, Rochester, New York

12. University of Florida, Gainesville, Florida

13. Children’s National Hospital, Washington, DC

14. Emory University, Atlanta, Georgia

15. Mayo Clinic, Rochester, Minnesota

16. Harms Study Group/Setting Scoliosis Straight Foundation, El Cajon, California

17. University of Minnesota, Minneapolis, Minnesota

18. Ecole Polytechnique, St. Justine Hospital, Montreal, Quebec, Canada

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Orthopedics and Sports Medicine,General Medicine,Surgery

Reference38 articles.

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2. Scoliosis: incidence and natural history. A prospective epidemiological study;Rogala;J Bone Joint Surg Am.,1978

3. The incidence of scoliosis in the state of Delaware; a study of 50,000 minifilms of the chest made during a survey for tuberculosis;Shands;J Bone Joint Surg Am.,1955

4. Scoliosis prevalence: a call for a statement of terms;Kane;Clin Orthop Relat Res.,1977

5. Trends in Incidence of Adolescent Idiopathic Scoliosis: A Modern US Population-based Study;Thomas;J Pediatr Orthop.,2021

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