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Does obesity affect outcomes of treatment for lumbar stenosis and degenerative spondylolisthesis? Analysis of the Spine Patient Outcomes Research Trial (SPORT).

ABSTRACT: Retrospective subgroup analysis of prospectively collected data according to treatment received.The purpose of this study was to determine whether obesity affects treatment outcomes for lumbar stenosis (SpS) and degenerative spondylolisthesis (DS).Obesity is thought to be associated with increased complications and potentially less favorable outcomes after the treatment of degenerative conditions of the lumbar spine. This, however, remains a matter of debate in the existing literature.An as-treated analysis was performed on patients enrolled in the Spine Patient Outcomes Research Trial for the treatment of SpS or DS. A comparison was made between patients with a body mass index (BMI) of less than 30 ("nonobese," n = 373 SpS and 376 DS) and those with a BMI of 30 or more ("obese," n = 261 SpS and 225 DS). Baseline patient characteristics, intraoperative data, and complications were documented. Primary and secondary outcomes were measured at baseline and regular follow-up time intervals up to 4 years. The difference in improvement over baseline between surgical and nonsurgical treatment (i.e., treatment effect) was determined at each follow-up interval for the obese and nonobese groups.At 4-year follow-up, operative and nonoperative treatment provided improvement in all primary outcome measures over baseline in patients with BMI of less than 30 and 30 or more. For patients with SpS, there were no differences in the surgical complication or reoperation rates between groups. Patients with DS with BMI of 30 or more had a higher postoperative infection rate (5% vs. 1%, P = 0.05) and twice the reoperation rate at 4-year follow-up (20% vs. 11%, P = 0.01) than those with BMI of less than 30. At 4 years, surgical treatment of SpS and DS was equally effective in both BMI groups in terms of the primary outcome measures, with the exception that obese patients with DS had less improvement from baseline in the 36-Item Short Form Health Survey (SF-36) physical function score than nonobese patients (22.6 vs. 27.9, P = 0.022). With nonoperative treatment, patients with SpS with BMI of 30 or more did worse in regard to all 3 primary outcome measures, and patients with DS with BMI of 30 or more had similar SF-36 bodily pain scores but less improvement over baseline in the SF-36 physical function and Oswestry Disability Index scores. Treatment effects for SpS and DS were significant within each BMI group for all primary outcome measures in favor of surgery. Obese patients had a significantly greater treatment effect than nonobese patients with SpS (Oswestry Disability Index, P = 0.037) and DS (SF-36 PF, P = 0.004) largely due to the relatively poor outcome of nonoperative treatment in obese patients.Obesity does not affect the clinical outcome of operative treatment of SpS. There are higher rates of infection and reoperation and less improvement from baseline in the SF-36 physical function score in obese patients after surgery for DS. Nonoperative treatment may not be as effective in obese patients with SpS or DS.

SUBMITTER: Rihn JA

PROVIDER: S-EPMC3757558 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature

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Does obesity affect outcomes of treatment for lumbar stenosis and degenerative spondylolisthesis? Analysis of the Spine Patient Outcomes Research Trial (SPORT).

Rihn Jeffrey A JA Radcliff Kristen K Hilibrand Alan S AS Anderson David T DT Zhao Wenyan W Lurie Jon J Vaccaro Alexander R AR Freedman Mitch K MK Albert Todd J TJ Weinstein James N JN

Spine 20121101 23

<h4>Study design</h4>Retrospective subgroup analysis of prospectively collected data according to treatment received.<h4>Objective</h4>The purpose of this study was to determine whether obesity affects treatment outcomes for lumbar stenosis (SpS) and degenerative spondylolisthesis (DS).<h4>Summary of background data</h4>Obesity is thought to be associated with increased complications and potentially less favorable outcomes after the treatment of degenerative conditions of the lumbar spine. This, ...[more]

PMID: 22614793

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Project description:BackgroundThe purpose of this study was to determine whether surgery is an effective option for the treatment of stenosis of the lumbar spine and degenerative spondylolisthesis in the octogenarian population.MethodsAn as-treated analysis of patients with lumbar stenosis and degenerative spondylolisthesis enrolled in the Spine Patient Outcomes Research Trial (SPORT) was performed. Patients who were at least eighty years of age (n = 105) were compared with those younger than eighty years (n = 1130). Baseline patient and clinical characteristics were noted, and the difference in improvement from baseline between operative and nonoperative treatment was determined for each group at each follow-up time period up to four years.ResultsThere were no significant baseline differences in the primary or secondary patient-reported clinical outcome measures between the two patient age groups. Patients at least eighty years of age had higher prevalences of multilevel stenosis, severe stenosis, and asymmetric motor weakness. Patients at least eighty years of age also had higher prevalences of hypertension, heart disease, osteoporosis, and joint problems at baseline, but they had a lower body mass index and lower prevalences of depression and smoking. Fifty-eight of the 105 patients at least eighty years of age and 749 of the 1130 younger patients underwent operative management. There were no differences in the rates of intraoperative or postoperative complications, reoperation, or postoperative mortality between the older and younger groups. Averaged over a four-year follow-up period, operatively treated patients at least eighty years of age had significantly greater improvement in all primary and secondary outcome measures compared with nonoperatively treated patients. The treatment effects in patients at least eighty years of age were similar to those in younger patients for all primary and secondary measures except the SF-36 (Short Form-36) bodily pain domain and the percentage who self-rated their progress as a major improvement, in both of which the treatment effect was significantly smaller.ConclusionsOperative treatment of lumbar stenosis and degenerative spondylolisthesis offered a significant benefit over nonoperative treatment in patients at least eighty years of age (p < 0.05). There were no significant increases in the complication and mortality rates following surgery in this patient population compared with younger patients (p > 0.05).

Project description:Retrospective review of a prospectively collected database.To examine whether short- and long-term outcomes after surgery for lumbar stenosis (SPS) and degenerative spondylolisthesis (DS) vary across centers.Surgery has been shown to be of benefit for both SPS and DS. For both conditions, surgery often consists of laminectomy with or without fusion. Potential differences in outcomes of these overlapping procedures across various surgical centers have not yet been investigated.Spine Patient Outcomes Research Trial cohort participants with a confirmed diagnosis of SPS or DS undergoing surgery were followed from baseline at 6 weeks, 3, 6, and 12 months, and yearly thereafter, at 13 spine clinics in 11 US states. Baseline characteristics and short- and long-term outcomes were analyzed.A total of 793 patients underwent surgery. Significant differences were found between centers with regard to patient race, body mass index, treatment preference, neurological deficit, stenosis location, severity, and number of stenotic levels. Significant differences were also found in operative duration and blood loss, the incidence of durotomy, the length of hospital stay, and wound infection. When baseline differences were adjusted for, significant differences were still seen between centers in changes in patient functional outcome (Short Form-36 bodily pain and physical function, and Oswestry Disability Index) at 1 year after surgery. In addition, the cumulative adjusted change in the Oswestry Disability Index Score at 4 years significantly differed among centers, with Short Form-36 scores trending toward significance.There is a broad and statistically significant variation in short- and long-term outcomes after surgery for SPS and DS across various academic centers, when statistically significant baseline differences are adjusted for. The findings suggest that the choice of center affects outcome after these procedures, although further studies are required to investigate which center characteristics are most important.

Project description:BackgroundThe management of degenerative spondylolisthesis associated with spinal stenosis remains controversial. Surgery is widely used and has recently been shown to be more effective than nonoperative treatment when the results were followed over two years. Questions remain regarding the long-term effects of surgical treatment compared with those of nonoperative treatment.MethodsSurgical candidates from thirteen centers with symptoms of at least twelve weeks' duration as well as confirmatory imaging showing degenerative spondylolisthesis with spinal stenosis were offered enrollment in a randomized cohort or observational cohort. Treatment consisted of standard decompressive laminectomy (with or without fusion) or usual nonoperative care. Primary outcome measures were the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index at six weeks, three months, six months, and yearly up to four years.ResultsIn the randomized cohort (304 patients enrolled), 66% of those randomized to receive surgery received it by four years whereas 54% of those randomized to receive nonoperative care received surgery by four years. In the observational cohort (303 patients enrolled), 97% of those who chose surgery received it whereas 33% of those who chose nonoperative care eventually received surgery. The intent-to-treat analysis of the randomized cohort, which was limited by nonadherence to the assigned treatment, showed no significant differences in treatment outcomes between the operative and nonoperative groups at three or four years. An as-treated analysis combining the randomized and observational cohorts that adjusted for potential confounders demonstrated that the clinically relevant advantages of surgery that had been previously reported through two years were maintained at four years, with treatment effects of 15.3 (95% confidence interval, 11 to 19.7) for bodily pain, 18.9 (95% confidence interval, 14.8 to 23) for physical function, and -14.3 (95% confidence interval, -17.5 to -11.1) for the Oswestry Disability Index. Early advantages (at two years) of surgical treatment in terms of the secondary measures of bothersomeness of back and leg symptoms, overall satisfaction with current symptoms, and self-rated progress were also maintained at four years.ConclusionsCompared with patients who are treated nonoperatively, patients in whom degenerative spondylolisthesis and associated spinal stenosis are treated surgically maintain substantially greater pain relief and improvement in function for four years.

Project description:Clinical trial subgroup analysis.To compare outcomes of different fusion techniques treating degenerative spondylolisthesis (DS). Summary of Background Data. Surgery has been shown to be more effective than nonoperative treatment out to 4 years. Questions remain regarding the differential effect of fusion technique.Surgical candidates from 13 centers in 11 states with at least 12 weeks of symptoms and confirmatory imaging showing stenosis and DS were studied. In addition to standard decompressive laminectomy, 1 of 3 fusion techniques was employed at the surgeon's discretion: posterolateral in situ fusion (PLF); posterolateral instrumented fusion with pedicle screws (PPS); or PPS plus interbody fusion (360 degrees). Main outcome measures were the SF-36 bodily pain (BP) and physical function (PF) scales and the modified Oswestry Disability Index (ODI) assessed at 6 weeks, 3 months, 6 months, and yearly to 4 years. The as-treated analysis combined the randomized and observational cohorts using mixed longitudinal models adjusting for potential confounders.Of 380 surgical patients, 21% (N = 80) received a PLF; 56% (N = 213) received a PPS; 17% (N = 63) received a 360 degrees; and 6% (N = 23) had decompression only without fusion. Early outcomes varied, favoring PLF compared to PPS at 6 weeks (PF: 12.73 vs. 6.22, P < 0.020) and 3 months (PF: 25.24 vs.18.95, P < 0.025) and PPS compared to 360 degrees at 6 weeks (ODI: -14.46 vs. -9.30, P < 0.03) and 3 months (ODI: -22.30 vs. -16.78, P < 0.02). At 2 years, 360 degrees had better outcomes: BP: 39.08 versus 29.17 PLF, P < 0.011; and versus 29.13 PPS, P < 0.002; PF: 31.93 versus 23.27 PLF, P < 0.021; and versus 25.29 PPS, P < 0.036. However, these differences were not maintained at 3- and 4-year follow-up, when there were no statistically significant differences between the 3 fusion groups.In patients with DS and associated spinal stenosis, no consistent differences in clinical outcomes were seen among fusion groups over 4 years.

Project description:BackgroundThere is considerable controversy about the long-term morbidity associated with the use of posterior autologous iliac crest bone graft for lumbar spine fusion procedures compared with the use of bone-graft substitutes. The hypothesis of this study was that there is no long-term difference in outcome for patients who had posterior lumbar fusion with or without iliac crest autograft.MethodsThe study population includes patients enrolled in the degenerative spondylolisthesis cohort of the Spine Patient Outcomes Research Trial who underwent lumbar spinal fusion. Patients were divided according to whether they had or had not received posterior autologous iliac crest bone graft.ResultsThere were 108 patients who had fusion with iliac crest autograft and 246 who had fusion without iliac crest autograft. There were no baseline differences between groups in demographic characteristics, comorbidities, or baseline clinical scores. At baseline, the group that received iliac crest bone graft had an increased percentage of patients who had multilevel fusions (32% versus 21%; p=0.033) and L5-S1 surgery (37% versus 26%; p=0.031) compared with the group without iliac crest autograft. Operative time was higher in the iliac crest bone-graft group (233.4 versus 200.9 minutes; p<0.001), and there was a trend toward increased blood loss (686.9 versus 582.3; p=0.057). There were no significant differences in postoperative complications, including infection or reoperation rates, between the groups. On the basis of the numbers available, no significant differences were detected between the groups treated with or without iliac crest bone graft with regard to the scores on Short Form-36, Oswestry Disability Index, Stenosis Bothersomeness Index, and Low Back Pain Bothersomeness Scale or the percent of patient satisfaction with symptoms averaged over the study period.ConclusionsThe outcome scores associated with the use of posterior iliac crest bone graft for lumbar spinal fusion were not significantly lower than those after fusion without iliac crest autograft. Conversely, iliac crest bone-grafting was not associated with an increase in the complication rates or rates of reoperation. On the basis of these results, surgeons may choose to use iliac crest bone graft on a case-by-case basis for lumbar spinal fusion.

Project description:BackgroundManagement of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials.MethodsSurgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years.ResultsWe enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment.ConclusionsIn nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].).

Project description:BackgroundQuestions remain as to the effect that obesity has on patients managed for symptomatic lumbar disc herniation. The purpose of this study was to determine if obesity affects outcomes following the treatment of symptomatic lumbar disc herniation.MethodsAn as-treated analysis was performed on patients enrolled in the Spine Patient Outcomes Research Trial for the treatment of lumbar disc herniation. A comparison was made between patients with a body mass index of <30 kg/m² (nonobese) (n = 854) and those with a body mass index of ≥30 kg/m² (obese) (n = 336). Baseline patient demographic and clinical characteristics were documented. Primary and secondary outcomes were measured at baseline and at regular follow-up time intervals up to four years. The difference in improvement from baseline between operative and nonoperative treatment was determined at each follow-up period for both groups.ResultsAt the time of the four-year follow-up evaluation, improvements over baseline in primary outcome measures were significantly less for obese patients as compared with nonobese patients in both the operative treatment group (Short Form-36 physical function, 37.3 compared with 47.7 points [p < 0.001], Short Form-36 bodily pain, 44.2 compared with 50.0 points [p = 0.005], and Oswestry Disability Index, -33.7 compared with -40.1 points [p < 0.001]) and the nonoperative treatment group (Short Form-36 physical function, 23.1 compared with 32.0 points [p < 0.001] and Oswestry Disability Index, -21.4 compared with -26.1 points [p < 0.001]). The one exception was that the change from baseline in terms of the Short Form-36 bodily pain score was statistically similar for obese and nonobese patients in the nonoperative treatment group (30.9 compared with 33.4 points [p = 0.39]). At the time of the four-year follow-up evaluation, when compared with nonobese patients who had been managed operatively, obese patients who had been managed operatively had significantly less improvement in the Sciatica Bothersomeness Index and the Low Back Pain Bothersomeness Index, but had no significant difference in patient satisfaction or self-rated improvement. In the present study, 77.5% of obese patients and 86.9% of nonobese patients who had been managed operatively were working a full or part-time job. No significant differences were observed in the secondary outcome measures between obese and nonobese patients who had been managed nonoperatively. The benefit of surgery over nonoperative treatment was not affected by body mass index.ConclusionsObese patients realized less clinical benefit from both operative and nonoperative treatment of lumbar disc herniation. Surgery provided similar benefit over nonoperative treatment in obese and nonobese patients.

Project description:ContextFor patients with lumbar disk herniation, the Spine Patient Outcomes Research Trial (SPORT) randomized trial intent-to-treat analysis showed small but not statistically significant differences in favor of diskectomy compared with usual care. However, the large numbers of patients who crossed over between assigned groups precluded any conclusions about the comparative effectiveness of operative therapy vs usual care.ObjectiveTo compare the treatment effects of diskectomy and usual care.Design, setting, and patientsProspective observational cohort of surgical candidates with imaging-confirmed lumbar intervertebral disk herniation who were treated at 13 spine clinics in 11 US states and who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003.InterventionsStandard open diskectomy vs usual nonoperative care.Main outcome measuresChanges from baseline in the Medical Outcomes Study Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons/MODEMS version).ResultsOf the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care. At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain (mean change: surgery, 40.9 vs nonoperative care, 26.0; treatment effect, 14.8; 95% confidence interval, 10.8-18.9), physical function (mean change: surgery, 40.7 vs nonoperative care, 25.3; treatment effect, 15.4; 95% CI, 11.6-19.2), and Oswestry Disability Index (mean change: surgery, -36.1 vs nonoperative care, -20.9; treatment effect, -15.2; 95% CI, -18.5. to -11.8). These differences narrowed somewhat at 2 years: bodily pain (mean change: surgery, 42.6 vs nonoperative care, 32.4; treatment effect, 10.2; 95% CI, 5.9-14.5), physical function (mean change: surgery, 43.9 vs nonoperavtive care 31.9; treatment effect, 12.0; 95% CI; 7.9-16.1), and Oswestry Disability Index (mean change: surgery -37.6 vs nonoperative care -24.2; treatment effect, -13.4; 95% CI, -17.0 to -9.7).ConclusionsPatients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups. Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously.Trial registrationclinicaltrials.gov Identifier: NCT00000410.

Dataset Information

Does obesity affect outcomes of treatment for lumbar stenosis and degenerative spondylolisthesis? Analysis of the Spine Patient Outcomes Research Trial (SPORT).

Publications

Does obesity affect outcomes of treatment for lumbar stenosis and degenerative spondylolisthesis? Analysis of the Spine Patient Outcomes Research Trial (SPORT).

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