Dados do Trabalho

Título

Six Minimally Invasive Approaches For Lumbar Interbody Fusion Surgery In Adults Suffering From Degenerative Lumbar Disease: Real World Data At 1-Year Follow-Up From A Global Prospective Cohort Study.

Objetivo

Background/introduction
Minimally invasive (MI) lumbar interbody fusion (LIF) procedures are an effective treatment for patients with degenerative lumbar disease (DLD). However, consensus does not exist among surgeons for selecting one approach in favor of another for any given patient. It is not known if the surgeons’ choice of methods impacts the longer terms results.
Purpose of the study
This study aimed to collect patient reported, surgical and fusion outcome data at 1-year post-surgery on DLD patients indicated for MI-LIF using either ALIF, DLIF, OLIF, PLIF, TLIF or MIDLF.

Metodologia

A total of 340 DLD patients were consecutively enrolled in a prospective clinical study (MASTERS-D 2; NCT02617563) with 26 sites across Europe, Latin America, and Asia. Patients were treated according to the surgeon’s choice with one of 6 MI-LIF procedures (ALIF, OLIF, DLIF, PLIF, TLIF or MIDLF).
Outcome data for disability (ODI), back and leg pain (VAS), quality of life (EQ-5D) and demographic information were collected prior to and 1-year after the surgery. Surgical data, blood loss and adverse events were also recorded. Fusion status was assessed by the surgeon or hospital radiologist using CT-scan or X-rays at 1-year (±6-months) post-surgery. The criterion for fusion when assessed by CT-scan was bony bridging. When assessed by X-Rays the criteria was bony bridging, no motion (<4˚) in flexion/extension views and integrity of instrumentation.
Paired sample t-tests were used to test for improvement from baseline.

Resultados

One year after surgery, patients attained clinically significant improvements on all patient reported outcome measures regardless of approach used. (Table 1.)
Patients who were selected to receive an ALIF comprised the highest proportion of smokers, were the youngest, and had the longest operating time, but had low fluoroscopy exposure. Anterolateral (ALIF, DLIF, OLIF) compared to posterior (MIDLF, PLIF, TLIF) approaches had the least amount of blood loss, despite similar or longer surgical times.
Assessment of fusion in all patients was hindered by the effects of COVID-19. In total, 196 out of 340 (57.6%) patients were assessed. Fusion rates ranged from 79.2% (ALIF) to 100% (PLIF). The aggregate fusion rate for anterolateral approaches was 88.1% and for posterior approaches 85.1%.
Within the 1-year follow-up window, 7 device-related and 7 MI surgery-related serious adverse events (SAEs) had been recorded.

Conclusões

All 6 approaches for MI-LIF surgery demonstrate favorable patient reported and surgical outcomes for DLD patients. Fusion rates at 1-year might reflect patient characteristics, inter-rater variability, or the small number of patients assessed in some sub-groups (e.g. PLIF, n=13), rather than the efficacy or risks of the surgical approach used. Continuing data collection up to 5 years post-surgery will yield information on long-term effectiveness, safety, health-economics and the long-term impact of surgeons’ choice of MI approach.