Return to Work, Activities of Daily Living and Disability Improvement: Twelve-Month Outcomes of an FDA IDE Trial of Decompression and Tension Band Stabilization for Degenerative Spondylolisthesis
Conference Proceeding - Restricted Access
BACKGROUND CONTEXTDegenerative spondylolisthesis (DS) with lumbar spinal stenosis (LSS) is commonly treated with decompression and fusion. The LimiFlex Dynamic Sagittal Tether (DST) is an investigational stabilization device for patients with DS and LSS.
PURPOSEAssess return to work (RTW) and activities of daily living (ADL) receiving either decompression and DST stabilization (D+DST) or decompression and transforaminal lumbar interbody fusion (D+TLIF).
STUDY DESIGN/SETTINGInterim analysis from a multicenter, concurrently controlled study.
PATIENT SAMPLEPatients undergoing treatment (D+DST or D+TLIF) of Grade I Meyerding lumbar DS. Propensity score (PS) selected patients with 12-month follow-up were included.
OUTCOME MEASURESTime to RTW and activities of daily living, as well as Oswestry disability index (ODI).
METHODSPS-selected IDE study subjects with 12 months of follow-up were included in this analysis. Study records queried for work status preoperatively and at 12 months, as well as time to RTW and ADL, and change in disability (Oswestry Disability Index; ODI) at 12 months vs preop. Outcomes were compared using student's t-tests.
RESULTSPS-selected subjects totaled 267 (136 D+DST, 131 D+TLIF). Preoperatively, 49% of D+DST and 43% of D+TLIF subjects were working (p=0.14) and 7% D+DST and 11% D+TLIF were not working due to spinal condition (NWSC) (p=0.13). At 12 months postop, 44% of D+DST and 34% of D+TLIF subjects were working (p=0.05) and 2% D+DST and 10% D+TLIF were NWSC (p<0.01). Proportion of D+DST NWSC was significantly lower 12 months postop compared to preop (p=0.02). Mean±SD RTW time for D+DST/D+TLIF subjects was 5.4±6.6/11.8±9.6 weeks (p<0.01) and return to ADL time was 5.5±6.5/10.0±9.5 weeks (p<0.01). Mean±SD reduction in disability at 12 months from baseline was 38.1±18.4 for the D+DST group and 31.8±20.7 for the D+TLIF group (p<0.01) with effect sizes of -2.1 and -1.5, respectively.
CONCLUSIONSThe primary objective of surgery for symptomatic DS is resolution of symptoms so patients can return to their normal ADL and work. Both D+DST and D+TLIF treated patients demonstrated a significant reduction in disability at 12-month follow-up. Significantly faster RTW and ADL were observed for D+DST compared to D+TLIF patients, by an average of more than 5 weeks. The proportion of D+DST patients NWSC was significantly less than at 12 months. Results indicate a significant advantage of earlier recovery for the D+DST patients allowing earlier RTW and earlier increase in ADLs compared to D+TLIF, with similar or greater improvements in disability after one year for patients treated with decompression and stabilization for symptomatic DS. Longer-term follow-up assessment with propensity score-adjusted outcomes will demonstrate whether this advantage and long-term outcomes are durable and generalizable.
Lavelle WF, Sasso RC, Hu SS, Bae HW, Yoon ST, Villavicencio AT, et al. [Perez-Cruet MJ, Fischgrund JS]. Spine J. 2022 Sep;22(9 Suppl):S12. doi:10.1016/j.spinee.2022.06.038.
North American Spine Society 37th Annual Meeting, October 12-15, 2022, Chicago, IL.