Dados do Trabalho

Título

Clinical outcomes and fusion success in patients with degenerative lumbar disease without spondylolisthesis: comparing anterolateral to posterior MIS approaches

Objetivo

Minimally invasive (MI) lumbar interbody fusion (LIF) approaches are used to treat patients with degenerative lumbar disease (DLD). It is uncertain if patients receiving an anterolateral or posterior approach achieve similar outcomes. This study aimed to generate real-world evidence of effectiveness and safety of anterolateral and posterior MI-LIF approaches.

Metodologia

Patient reported outcomes (PROMs) were collected using ODI, VAS scales to measure back and leg pain, and EQ-5D. Fusion status was assessed by CT-scan or radiography.
Methods
DLD patients without spondylolisthesis indicated for anterolateral (ALIF, DLIF, OLIF) or posterior (MIDLF, PLIF, TLIF) MI-LIF surgery were consecutively enrolled (n=109) in a multi-center prospective clinical study (NCT02617563) in Brazil, Argentina, Mexico, Asia, and Europe. Each procedure was completed by an MI experienced surgeon who chose the approach for each patient. PROMS were collected at baseline, 4-weeks, 3- and 12-months post-surgery. Fusion status was assessed at 1-year (± 6-months). Paired t-test and ANCOVA were used to test for improvements from baseline and between group differences.

Resultados

Fifty of 109 patients received anterolateral MI-LIF (58% 1-level; 42% 2-level) and 59 patients received posterior MI-LIF (86% 1-level, 14% 2-level). Stenosis was less common in patients who underwent anterolateral (60% first level, 52% second level) compared to posterior (78% at first level, 88% at second level) MI-LIF procedures.
At 1-year post-surgery, patients reported on average, statistically significant and clinically important improvements on all outcome measures compared to baseline regardless of approach used. There were no statistically significant differences in the level of improvement between patients receiving an anterolateral or posterior approach for ODI, leg pain and EQ5D index score. Patients treated with a posterior approach had a greater reduction in back pain compared with anterolateral treated patients (p =0.017). Overall, 87% of patients assessed achieved fusion by 1-year (anterolateral group 91.2%, posterior group 82.9%). One MI-LIF procedure-related and one device-related SAE in the anterolateral group were reported.

Conclusões

Despite the anterolateral group having a higher percentage of patients requiring a 2-level MI-LIF compared to the posterior group, the fusion rates and PROMs were similar; the exception being for the reduction in back pain which favored the posterior group. It is not clear if surgeons are matching the approach to the patient, or if it does not matter which approach is used. It is important for clinical guidelines that patient profiles are defined to establish who is most likely to benefit from which approach.