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

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00000409.

Figures

Figure 1

Exclusion, Enrollment, Randomization and Follow-up of Trial Participants The values or surgery, withdrawal, and death are cumulative over four years. For example, a total of 3 patients in the group assigned to surgery died during the 4-year follow-up period [Dataset 05/01/2008]

Figure 2

Summary of fusion group pattern of results for the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the Oswestry Disability Index (ODI)

Figure 2

Summary of fusion group pattern of results for the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the Oswestry Disability Index (ODI)

Figure 2

Summary of fusion group pattern of results for the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the Oswestry Disability Index (ODI)

Figure 3

Summary of fusion group pattern of results for Stenosis Bothersomeness and Back Pain Bothersomeness Indices.

Figure 3

Summary of fusion group pattern of results for Stenosis Bothersomeness and Back Pain Bothersomeness Indices.