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Randomized Controlled Trial
. 2019 Feb 20;101(4):338-352.
doi: 10.2106/JBJS.18.00483.

Operative Versus Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis

Michael P Kelly  1 , Jon D Lurie  2 , Elizabeth L Yanik  1 , Christopher I Shaffrey  3 , Christine R Baldus  1 , Oheneba Boachie-Adjei  4 , Jacob M Buchowski  1 , Leah Y Carreon  5 , Charles H Crawford 3rd  5 , Charles Edwards 2nd  6 , Thomas J Errico  7 , Steven D Glassman  5 , Munish C Gupta  1 , Lawrence G Lenke  8 , Stephen J Lewis  9 , Han Jo Kim  10 , Tyler Koski  11 , Stefan Parent  12 , Frank J Schwab  10 , Justin S Smith  3 , Lukas P Zebala  1 , Keith H Bridwell  1
Affiliations
Randomized Controlled Trial

Operative Versus Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis

Michael P Kelly et al. J Bone Joint Surg Am. .

Erratum in

Abstract

Background: The effectiveness of operative compared with nonoperative treatment at initial presentation (no prior fusion) for adult lumbar scoliosis has not, to our knowledge, been evaluated in controlled trials. The goals of this study were to evaluate the effects of operative and nonoperative treatment and to assess the benefits of these treatments to help treating physicians determine whether patients are better managed operatively or nonoperatively.

Methods: Patients with adult symptomatic lumbar scoliosis (aged 40 to 80 years, with a coronal Cobb angle measurement of ≥30° and an Oswestry Disability Index [ODI] score of ≥20 or Scoliosis Research Society [SRS]-22 score of ≤4.0) from 9 North American centers were enrolled in concurrent randomized or observational cohorts to evaluate operative versus nonoperative treatment. The primary outcomes were differences in the mean change from baseline in the SRS-22 subscore and ODI at 2-year follow-up. For the randomized cohort, the initial sample-size calculation estimated that 41 patients per group (82 total) would provide 80% power with alpha equal to 0.05, anticipating 10% loss to follow-up and 20% nonadherence in the nonoperative arm. However, an interim sample-size calculation estimated that 18 patients per group would be sufficient.

Results: Sixty-three patients were enrolled in the randomized cohort: 30 in the operative group and 33 in the nonoperative group. Two hundred and twenty-three patients were enrolled in the observational cohort: 112 in the operative group and 111 in the nonoperative group. The intention-to-treat analysis of the randomized cohort found that, at 2 years of follow-up, outcomes did not differ between the groups. Nonadherence was high in the randomized cohort (64% nonoperative-to-operative crossover). In the as-treated analysis of the randomized cohort, operative treatment was associated with greater improvement at the 2-year follow-up in the SRS-22 subscore (adjusted mean difference, 0.7 [95% confidence interval (CI), 0.5 to 1.0]) and in the ODI (adjusted mean difference, -16 [95% CI, -22 to -10]) (p < 0.001 for both). Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001). In an overall responder analysis, more operative patients achieved improvement meeting or exceeding the minimal clinically important difference (MCID) in the SRS-22 subscore (85.7% versus 38.7%; p < 0.001) and the ODI (77.4% versus 38.3%; p < 0.001). Thirty-four revision surgeries were performed in 24 (14%) of the operative patients.

Conclusions: On the basis of as-treated and MCID analyses, if a patient with adult symptomatic lumbar scoliosis is satisfied with current spine-related health, nonoperative treatment is advised, with the understanding that improvement is unlikely. If a patient is not satisfied with current spine health and expects improvement, surgery is preferred.

Level of evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

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Figures

Fig. 1
Fig. 1
Flow of participants from screening and enrollment through 2-year follow-up (F/U) in the randomized and observational cohorts. Follow-up time points indicate the time since first treatment occurred. The numbers of those who withdrew, died, or underwent surgery are cumulative across follow-up time points. Individuals who opted for surgery outside of the study were counted as patients who underwent surgery and as withdrawals at the time of surgery. Withdrawal counts do not include deaths.
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See this image and copyright information in PMC

Comment in

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