ABSTRACT
BACKGROUND: Surgery for lumbar disc herniation (LDH) has had a remarkable technological development during the past 20 years. Microscopic discectomy has traditionally been the gold standard method to treat symptomatic LDH before the introduction of full-endoscopic lumbar discectomy (FELD). The FELD procedure allows unsurpassed magnification and visualization and is currently the most minimally invasive surgical technique. In this study, FELD was compared with standard surgery for LDH, with a focus on medically relevant changes in patient-reported outcome measures (PROMs). PURPOSE: The purpose of this study was to investigate whether FELD is noninferior to other surgical methods for LDH surgery in the most common PROMs, including postoperative leg pain and disability, while still reaching the necessary thresholds for relevant clinical and medical improvements. METHODS: Patients undergoing a FELD procedure at the Sahlgrenska University Hospital, Gothenburg, Sweden, between 2013 to 2018 were included. A total of 80 (41 men and 39 women) patients were enrolled. The FELD patients were matched 1:5 to controls from the Swedish spine register (Swespine) who had a standard microscopic or mini-open discectomy surgery. PROMs, including the Oswestry Disability Index (ODI) and the Numerical Rating Scale (NRS), as well as the patient acceptable symptom states (PASS) and the minimal important change (MIC), were used to compare the efficacy of the 2 surgical approaches. RESULTS: The FELD group achieved medically relevant and significant improvements noninferior to standard surgery within the predefined thresholds of MIC and PASS. No differences could be found in disability measured by ODI FELD -28.4 (SD 19.2) vs standard surgery -28.7 (SD 18.9) or leg pain NRSLeg FELD -4.35 (SD 2.93) vs standard surgery -4.99 (SD 3.12). All intragroup score changes were significant. CONCLUSIONS: The FELD results are not inferior to standard surgery 1 year postoperatively after LDH surgery. There were no medically significant differences regarding MIC achieved or final PASS in any of the measured PROMs, including leg pain, back pain, or disability (ODI) between the surgical methods. CLINICAL RELEVANCE: The present study highlights that FELD is noninferior to standard surgery in clinically relevant PROMs.
ABSTRACT
BACKGROUND: The introduction of full-endoscopic lumbar discectomy (FELD) procedures has made it possible to challenge microscopic discectomy as the gold standard method to treat lumbar disc herniations. PURPOSE: The aim of the present study is to investigate the introductory-phase postoperative clinical improvement for FELD patients regarding leg pain, patient-reported outcome measurements (PROMs), complications, reoperations, and learning curve analysis. METHODS: All patients who underwent FELD at Sahlgrenska University Hospital, Sweden, were prospectively included during 2013- 2017. A total of 92 patients were enrolled and followed up for 1 year. The characteristics of the study population, degree of leg pain, complications, learning curve, and PROMs were retrieved from patient records and the National Quality Register for Spine Surgery (Swespine). RESULTS: The postoperative results demonstrated major improvements; leg pain measured by a numerical rating scale (0-10) decreased from 7.4 ± 2.25 to 2.76 ± 2.70, with a mean improvement of -4.54, (-3.62-5.46) 95% confidence interval (CI). The Oswestry Disability Index decreased by 30.48 (-36.27-23.73) with a 95% CI, and the EuroQol-5D increased by 0.39 (0.21-0.57) 95% CI. An assessment of the final surgical result showed that 91.6% ranked their general situation as better or much better. Specifically, regarding postoperative leg pain, 87% regarded their leg pain as completely gone, much better, or somewhat better, while 13% regarded their leg pain as unchanged or worse. A learning curve analysis showed that for every 10th FELD procedure performed; the duration of surgery decreased by 2 minutes. CONCLUSIONS: In our study, the introduction of FELD as a safe, quick procedure for the treatment of lumbar disc herniations can yield significant gains in patient-reported outcome measurements and pain reduction. The rate of recurrence and complications is comparable to that of standard surgery.