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Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial.

ABSTRACT: 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.

SUBMITTER: Abdu WA

PROVIDER: S-EPMC3750746 | biostudies-literature | 2009 Oct

REPOSITORIES: biostudies-literature

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Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial.

Abdu William A WA Lurie Jon D JD Spratt Kevin F KF Tosteson Anna N A AN Zhao Wenyan W Tosteson Tor D TD Herkowitz Harry H Longely Michael M Boden Scott D SD Emery Sanford S Weinstein James N JN

Spine 20091001 21

<h4>Study design</h4>Clinical trial subgroup analysis.<h4>Objective</h4>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.<h4>Methods</h4>Surgical candidates from 13 centers in 11 states with at least 12 weeks of symptoms and confirmatory imaging showing stenosis an ...[more]

PMID: 19755935

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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: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:BackgroundClinically, there are substantive practice variations in surgical management of degenerative lumbar spondylolisthesis. We aimed at evaluating whether decompression alone outcomes for patients with degenerative lumbar spondylolisthesis are comparable to those of decompression with fusion.MethodsIn this meta-analysis, the Embase, PubMed, and Cochrane Library databases were searched from inception to February 16th, 2022. Randomised controlled trials (RCTs) and cohort studies comparing decompression alone with decompression and fusion for patients with degenerative lumbar spondylolisthesis were included in this study. There were no language limitations. Odds ratio (OR), mean difference (MD) and 95% confidence interval (CI) were used to report results in the random-effects model. Main outcomes included Oswestry disability index (ODI), pain, clinical satisfaction, complication and reoperation rates. The study protocol was published in PROSPERO (CRD42022310645).FindingsThirty-three studies (6 RCTs and 27 cohort studies) involving 94 953 participants were included. Differences in post-operative ODI between decompression alone and decompression with fusion were not significant. A small difference for back (MD, 0.13; [95% CI, 0.08 to 0.18]; I 2:0.00%) and leg pain (MD, 0.30; [95% CI, 0.09 to 0.51]; I 2:48.35%) was observed on the 3rd post-operative month. The results did not reveal significant differences in leg pain and back pain between decompression alone and fusion groups on the 6th, 12th, and 24th post-operative months. Difference in clinical satisfaction between decompression alone and decompression with fusion were not significant from RCTs (OR, 0.26; [95% CI, 0.03 to 1.92]; I 2:83.27%). Complications (OR, 1.54; [95% CI, 1.16 to 2.05]; I 2:48.88%), operation time (MD, 83.39; [95% CI, 55.93 to 110.85]; I 2:98.75%), intra-operative blood loss (MD, 264.58; [95% CI, 174.99 to 354.16]; I 2:95.61%) and length of hospital stay (MD, 2.85; [95% CI, 1.60 to 4.10]; I 2:99.49%) were higher with fusion.InterpretationClinical effectiveness of decompression alone was comparable to that of decompression with fusion for degenerative lumbar spondylolisthesis. Decompression alone is recommended for patients with degenerative lumbar spondylolisthesis.FundingThis work was supported by grants from the National Natural Science Foundation of China (No. 81871818), Tangdu Hospital Seed Talent Program (Fei-Long Wei), Natural Science Basic Research Plan in Shaanxi Province of China (No.2019JM-265) and Social Talent Fund of Tangdu Hospital (No.2021SHRC034).

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: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).

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Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial.

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Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial.

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