Surgical Data and Early Postoperative Outcomes after Minimally Invasive Lumbar Interbody Fusion: Results of a Prospective, Multicenter, Observational Data-Monitored Study

Abstract

Minimally invasive lumbar interbody fusion (MILIF) offers potential for reduced operative morbidity and earlier recovery compared with open procedures for patients with degenerative lumbar disorders (DLD). Firm conclusions about advantages of MILIF over open procedures cannot be made because of limited number of large studies of MILIF in a real-world setting. Clinical effectiveness of MILIF in a large, unselected real-world patient population was assessed in this Prospective, monitored, international, multicenter, observational study. Objective: To observe and document short-term recovery after minimally invasive interbody fusion for DLD. Materials and Methods: In a predefined 4-week analysis from this study, experienced surgeons (≥30 MILIF surgeries pre-study) treated patients with DLD by one- or two-level MILIF. The primary study objective was to document patients’ short-term post-interventional recovery (primary objective) including back/leg pain (visual analog scale [VAS]), disability (Oswestry Disability Index [ODI]), health status (EQ-5D) and Patient satisfaction. Results: At 4 weeks, 249 of 252 patients were remaining in the study; the majority received one-level MILIF (83%) and TLIF was the preferred approach (94.8%). For one-level (and two-level) procedures, surgery duration was 128 (182) min, fluoroscopy time 115 (154) sec, and blood-loss 164 (233) mL. Time to first ambulation was 1.3 days and time to study-defined surgery recovery was 3.2 days. Patients reported significantly (P < 0.0001) reduced back pain (VAS: 2.9 vs 6.2), leg pain (VAS: 2.5 vs 5.9), and disability (ODI: 34.5% vs 45.5%), and a significantly (P < 0.0001) improved health status (EQ-5D index: 0.61 vs 0.34; EQ VAS: 65.4 vs 52.9) 4 weeks postoperatively. One adverse event was classified as related to the minimally invasive surgical approach. No deep site infections or deaths were reported. Conclusions: For experienced surgeons, MILIF for DLD demonstrated early benefits (short time to first ambulation, early recovery, high patient satisfaction and improved patient-reported outcomes) and low major perioperative morbidity at 4 weeks postoperatively.

Pain and disability after first-time spinal fusion for lumbar degenerative disorders: a systematic review and meta-analysis

“…After assessment of full text, twenty-five studies fulfilled the eligibility criteria and were included for qualitative analysis. Boissiere et al [47], Kok et al [54], and Pereira et al [60] were excluded for the quantitative analysis because of an overlap in study population with Barrey et al [46], Kok et al [55], and Franke et al [68], respectively. Tables 1 and 2 show overall study and patient characteristics, respectively.…”

“…Only four studies [49,60,68,69] reported use of a published study protocol. Ghogawala et al [49], Franke et al [68], and Kanter et al [69] provided data at all follow-up intervals and thorough description of their primary and secondary outcome selection.…”

“…Ghogawala et al [49], Franke et al [68], and Kanter et al [69] provided data at all follow-up intervals and thorough description of their primary and secondary outcome selection. Pereira et al [60] described in their study protocol measurement of VAS (back pain and leg pain) and ODI at baseline, 4 weeks and 3, 6, and 12 months, but outcomes at 3-, 6-, and 12-month follow-up were not reported.…”

Surgical and Clinical Results of Minimally Invasive Spinal Fusion Surgery in an Unselected Patient Cohort of a Spinal Care Unit

“…In line with this trend, operative techniques, surgical devices, and intraoperative monitoring equipment have improved and have resulted in reduced peri‐procedural complication rates. Minimally invasive spinal surgery (MIS) is gaining more relevance, especially because the surgical tissue trauma is significantly reduced when compared to open surgical procedures. MIS performed by experienced surgeons have shown improved clinical outcomes and lower perioperative morbidities (e.g.…”

“…Therefore, the advantages of MIS include minimized intraoperative blood loss, reduced perioperative morbidity, and lower infection rates. It has been suggested, but for the time being remains uncertain, that these surgical advantages will translate into faster recoveries and earlier return of function in the patients treated.…”