Harold A. Wilkinson
Elizabeth L. Yanik, Michael P. Kelly, Jon D. Lurie, Christine R. Baldus, Christopher I. Shaffrey, Frank J. Schwab, Shay Bess, Lawrence G. Lenke, Adam LaBore and Keith H. Bridwell
Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS.
Patients 40–80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7).
Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence−lumbar lordosis (PI–LL) match (≤ 11°). Male patients and patients with more (> 11°) PI–LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes.
Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI–LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.
Atman Desai, Perry A. Ball, Kimon Bekelis, Jon D. Lurie, Sohail K. Mirza, Tor D. Tosteson and James N. Weinstein
Incidental durotomy is an infrequent but well-recognized complication during lumbar disc surgery. The effect of a durotomy on long-term outcomes is, however, controversial. The authors sought to examine whether the occurrence of durotomy during surgery impacts long-term clinical outcome.
Spine Patient Outcomes Research Trial (SPORT) participants who had a confirmed diagnosis of intervertebral disc herniation and were undergoing standard first-time open discectomy were followed up at 6 weeks and at 3, 6, and 12 months after surgery and annually thereafter at 13 spine clinics in 11 US states. Patient data from this prospectively gathered database were reviewed. As of May 2009, the mean (± SD) duration of follow-up among all of the intervertebral disc herniation patients whose data were analyzed was 41.5 ± 14.5 months (41.4 months in those with no durotomy vs 40.2 months in those with durotomy, p < 0.68). The median duration of follow-up among all of these patients was 47 months (range 1–95 months).
A total of 799 patients underwent first-time lumbar discectomy. There was an incidental durotomy in 25 (3.1%) of these cases. There were no significant differences between the durotomy and no-durotomy groups with respect to age, sex, race, body mass index, herniation level or type, or the prevalence of smoking, diabetes, or hypertension. When outcome differences between the groups were analyzed, the durotomy group was found to have significantly increased operative duration, operative blood loss, and length of inpatient stay. However, there were no significant differences in incidence rates for nerve root injury, postoperative mortality, additional surgeries, or SF-36 scores for Bodily Pain or Physical Function, or Oswestry Disability Index scores at 1, 2, 3, or 4 years.
Incidental durotomy during first-time lumbar discectomy does not appear to impact long-term outcome in affected patients.