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Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts.

ABSTRACT: The 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.Surgical 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.In 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.Compared 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.

SUBMITTER: Weinstein JN

PROVIDER: S-EPMC2686131 | biostudies-literature | 2009 Jun

REPOSITORIES: biostudies-literature

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Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts.

Weinstein James N JN Lurie Jon D JD Tosteson Tor D TD Zhao Wenyan W Blood Emily A EA Tosteson Anna N A AN Birkmeyer Nancy N Herkowitz Harry H Longley Michael M Lenke Lawrence L Emery Sanford S Hu Serena S SS

The Journal of bone and joint surgery. American volume 20090601 6

<h4>Background</h4>The 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.<h4>Methods</h4>Surgical candidates from thirteen centers with symptoms of at least twelve weeks' duration as wel ...[more]

PMID: 19487505

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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: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.

Project description:ContextLumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversial.ObjectiveTo assess the efficacy of surgery for lumbar intervertebral disk herniation.Design, setting, and patientsThe Spine Patient Outcomes Research Trial, a randomized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states. Patients were 501 surgical candidates (mean age, 42 years; 42% women) with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks.InterventionsStandard open diskectomy vs nonoperative treatment individualized to the patient.Main outcome measuresPrimary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons MODEMS version) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index, satisfaction with symptoms, self-reported improvement, and employment status.ResultsAdherence to assigned treatment was limited: 50% of patients assigned to surgery received surgery within 3 months of enrollment, while 30% of those assigned to nonoperative treatment received surgery in the same period. Intent-to-treat analyses demonstrated substantial improvements for all primary and secondary outcomes in both treatment groups. Between-group differences in improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes.ConclusionsPatients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period. Because of the large numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis.Trial registrationclinicaltrials.gov Identifier: NCT00000410.

Project description:Study designRetrospective subgroup analysis of prospectively collected data according to treatment received.ObjectiveThe purpose of this study was to determine whether obesity affects treatment outcomes for lumbar stenosis (SpS) and degenerative spondylolisthesis (DS).Summary of background dataObesity 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.MethodsAn 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.ResultsAt 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.ConclusionObesity 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.

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:BackgroundPedicle screw invasion of the proximal articular process will cause local articular process degeneration and acceleration, which is an important factor affecting adjacent segment degeneration. Although lumbar spondylolisthesis is a risk factor for screw invasion of the proximal joint, there is no clear conclusion regarding the two different types of spondylolisthesis. Therefore, the purpose of this study was to explore the influence of pedicle screw placement on proximal facet invasion in the treatment of degenerative spondylolisthesis and isthmic spondylolisthesis.MethodsIn total, 468 cases of lumbar spondylolisthesis treated by decompression and fusion in our hospital from January 2017 to January 2020 were included in this retrospective study. Among them, 238 cases were degenerative spondylolisthesis (group A), and 230 cases were isthmic spondylolisthesis (group B). Sex, age, body mass index, bone mineral density, preoperative visual analog scale (VAS) and Oswestry Disability Index (ODI) scores, postoperative VAS and ODI scores at 1 month and 3 months, and angle of the proximal facet joint at the last follow-up were recorded and compared between the two groups. The degree of pedicle screw invasion of the proximal facet joint was graded and compared by the SEO grading method.ResultsThere were no significant differences in sex, age, body mass index, bone mineral density, preoperative VAS and ODI scores, or proximal facet joint angle between the two groups (P > 0.05). There was no significant difference in VAS and ODI scores between the two groups at 1 month and 3 months after the operation (P > 0.05). The VAS score of group A at the last follow-up was 1 (1,2). The VAS score of group B at the last follow-up was 3 (1,3). The ODI score of group A at the last follow-up was 6(4,26). The ODI score of group B at the last follow-up was 15(8,36). The VAS and ODI scores of the two groups at the last follow-up were significantly different (P < 0.05). According to the SEO grading method, the invasion of the proximal articular process by pedicle screw placement in group A involved 320 cases in grade 0, 128 cases in grade I and 28 cases in grade II. In group B, there were 116 cases in grade 0, 248 cases in grade I and 96 cases in grade II, with a significant difference (P < 0.01).ConclusionIn summary, a certain number of cases involving screws invading the proximal facet joint occurred in the two different types of lumbar spondylolisthesis, but the number in the isthmic spondylolisthesis group was significantly higher than that in the degenerative spondylolisthesis group, which caused more trauma to the proximal facet joint and significantly affected the patient prognosis.

Project description:BackgroundDebate regarding effectiveness of surgical modalities contributes to a lack of consensus of decision making for surgical interventions. Furthermore, data regarding cost effectiveness, surgical operative time, resources, patient hospital stay and recovery is limited, particularly in the medium term for degenerative lumbar spondylolisthesis. The objective was to compare clinical outcomes following different fixation interventions treating degenerative lumbar spondylolisthesis.MethodsA retrospective cohort study using the British Spine Registry (BSR) of 1,838 patients aged ≥18 years. Five hundred and five patients undergoing posterior lumbar interbody fusion (PLIF) and 1,333 undergoing transforaminal lumbar interbody fusion (TLIF) with 6 months follow-up, were compared. Demographics, Oswestry Disability Index (ODI), Numerical Rating Scale (NRS) [back and leg], quality of life, complications and cost effectiveness were analysed.ResultsNRS (back and leg) demonstrated a statistically significant difference favouring TLIF at 6 months (P=0.04) and (P<0.05) respectively. There was no difference in ODI improvement at 6 months between PLIF and TLIF (P=0.620), but there was a statistically significant difference in ODI scores preoperatively between PLIF and TLIF (P<0.001). EQ-5D-5L-Health VAS (P=0.136) and EQ-5D-5L (P=0.655) did not show a statistically significant difference in improvement between PLIF and TLIF. Dural tear was the most common complication and was higher in the PLIF group (5.7%) but not statistically significant. Estimated blood loss was greater for PLIF (P=0.041). Implant cost (P<0.001) was higher for TLIF whereas theatre time was higher for PLIF (P=0.031).ConclusionsBoth PLIF and TLIF result in clinically significant improvements in ODI, NRS back pain and NRS leg pain, with superiority of TLIF for improvements in back and leg pain. Surgeons appeared to use ODI preoperatively to decide intervention with comparable improvements for both approaches. Average theatre time and blood loss volume was higher for PLIF. Factors like implant costs and costs of consumables were higher for TLIF. Costs merit further evaluation.

Dataset Information

Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts.

Publications

Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts.

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