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Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis.

Publication ,  Journal Article
Wright, JG; Donaldson, S; Howard, A; Stephens, D; Alman, B; Hedden, D
Published in: J Bone Joint Surg Am
December 2007

BACKGROUND: Although many techniques for the surgical treatment of scoliosis have been described, we are not aware of any randomized trials that have compared implant systems. The relationship between surgeons' preferences for implants and patient outcomes is unknown. The purpose of the present study was to compare quality of life and curve correction associated with use of the Moss Miami system and the Universal Spine System for spinal fusion in patients with adolescent idiopathic scoliosis. METHODS: The present study was a double-blind, randomized clinical trial. All adolescent patients with idiopathic scoliosis who were scheduled for posterior instrumentation and arthrodesis with or without anterior release were screened for eligibility. Patients were randomly allocated to treatment with either the Moss Miami system or the Universal Spine System. The primary outcome measure for this trial was Quality of Life Profile for Spinal Disorders. RESULTS: Of the 129 subjects who were enrolled in the trial, sixty (95%) of sixty-three from the Universal Spine System group and sixty (91%) of sixty-six from the Moss Miami group were included in the final analysis. Two years postoperatively, the total Quality of Life score did not differ by the clinically important value of 5.5 between the two groups (difference, 1.07; 95% confidence interval, -3.67 to 5.82; p = 0.66). The percentage of Cobb angle correction was not significantly different for thoracic curves (55.1% +/- 18.3% for the Moss Miami system group, compared with 54.1% +/- 18.7% for the Universal Spine System group) (difference, -1%; 95% confidence interval, -7% to 5%; p = 0.77) or lumbar curves (45.4% +/- 24.6% for the Moss Miami system group, compared with 41.9% +/- 26.8% for the Universal Spine System group) (difference, -4%; 95% confidence interval, -16% to 11%; p = 0.57). Although surgeons were more satisfied with the Universal Spine System (difference, 42%; 95% confidence interval, 29% to 55%; p < 0.0001), satisfaction ratings were not related to any surgical outcomes. CONCLUSIONS: The Moss Miami system and the Universal Spine Systems provided similar quality of life and curve correction. Surgeon preference may be an unreliable means of selecting implants from the patient outcomes perspective.

Duke Scholars

Published In

J Bone Joint Surg Am

DOI

EISSN

1535-1386

Publication Date

December 2007

Volume

89

Issue

12

Start / End Page

2684 / 2693

Location

United States

Related Subject Headings

  • Spinal Fusion
  • Scoliosis
  • Quality of Life
  • Practice Patterns, Physicians'
  • Patient Selection
  • Patient Satisfaction
  • Orthopedics
  • Male
  • Internal Fixators
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
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Wright, J. G., Donaldson, S., Howard, A., Stephens, D., Alman, B., & Hedden, D. (2007). Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis. J Bone Joint Surg Am, 89(12), 2684–2693. https://doi.org/10.2106/JBJS.F.00720
Wright, James G., Sandra Donaldson, Andrew Howard, Derek Stephens, Benjamin Alman, and Douglas Hedden. “Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis.J Bone Joint Surg Am 89, no. 12 (December 2007): 2684–93. https://doi.org/10.2106/JBJS.F.00720.
Wright JG, Donaldson S, Howard A, Stephens D, Alman B, Hedden D. Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis. J Bone Joint Surg Am. 2007 Dec;89(12):2684–93.
Wright, James G., et al. “Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis.J Bone Joint Surg Am, vol. 89, no. 12, Dec. 2007, pp. 2684–93. Pubmed, doi:10.2106/JBJS.F.00720.
Wright JG, Donaldson S, Howard A, Stephens D, Alman B, Hedden D. Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis. J Bone Joint Surg Am. 2007 Dec;89(12):2684–2693.

Published In

J Bone Joint Surg Am

DOI

EISSN

1535-1386

Publication Date

December 2007

Volume

89

Issue

12

Start / End Page

2684 / 2693

Location

United States

Related Subject Headings

  • Spinal Fusion
  • Scoliosis
  • Quality of Life
  • Practice Patterns, Physicians'
  • Patient Selection
  • Patient Satisfaction
  • Orthopedics
  • Male
  • Internal Fixators
  • Humans