STUDY DESIGN: Clinical trial subgroup analysis. OBJECTIVE: 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. METHODS: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. RESULTS: Of 380 surgical patients, 21% (N = 80) received aPLF; 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. CONCLUSION: In patients with DS and associated spinal stenosis, no consistent differences in clinical outcomes were seen among fusion groups over 4 years.
RCT Entities:
STUDY DESIGN: Clinical trial subgroup analysis. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: In patients with DS and associated spinal stenosis, no consistent differences in clinical outcomes were seen among fusion groups over 4 years.
Authors: J S Fischgrund; M Mackay; H N Herkowitz; R Brower; D M Montgomery; L T Kurz Journal: Spine (Phila Pa 1976) Date: 1997-12-15 Impact factor: 3.468
Authors: S J Atlas; R A Deyo; R B Keller; A M Chapin; D L Patrick; J M Long; D E Singer Journal: Spine (Phila Pa 1976) Date: 1996-08-01 Impact factor: 3.468
Authors: Kristian Høy; Cody Bünger; Bent Niederman; Peter Helmig; Ebbe Stender Hansen; Haisheng Li; Thomas Andersen Journal: Eur Spine J Date: 2013-04-13 Impact factor: 3.134