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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.To observe and document short-term recovery after minimally invasive interbody fusion for DLD.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.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.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.

SUBMITTER: Pereira P

PROVIDER: S-EPMC4374830 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Surgical data and early postoperative outcomes after minimally invasive lumbar interbody fusion: results of a prospective, multicenter, observational data-monitored study.

Pereira Paulo P Buzek David D Franke Jörg J Senker Wolfgang W Kosmala Arkadiusz A Hubbe Ulrich U Manson Neil N Rosenberg Wout W Assietti Roberto R Martens Frederic F Barbanti Brodano Giovanni G Scheufler Kai-Michael KM

PloS one 20150326 3

<h4>Unlabelled</h4>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, ...[more]

PMID: 25811615

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Project description:BackgroundMinimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and oblique lateral interbody fusion (OLIF) are widely used in the treatment of lumbar degenerative diseases. In the present study, a meta-analysis was conducted to compare the clinical and radiographic efficacy of these two procedures.MethodsA systematic literature review was performed, and the quality of retrieved studies was evaluated with the Newcastle-Ottawa Scale (NOS). Clinical outcomes, including operation time, intraoperative blood loss, improvement in Visual Analogue Scale (VAS), improvement in Oswestry Disability Index (ODI), Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) effectiveness rate and complications, in addition to radiographic outcomes, including restoration of disc height, disc angle, overall lumbar lordosis, fusion rate and subsidence, were extracted and input into a fixed or random effect model to compare the efficacy of MIS-TLIF and OLIF.ResultsSeven qualified studies were included. Clinically, OLIF resulted in less intraoperative blood loss and shorter operation time than MIS-TLIF. Improvement of VAS for leg pain was more obvious in the OLIF group (P < 0.0001), whereas improvement of VAS for back pain (P = 0.08) and ODI (P = 0.98) as well as JOABPEQ effectiveness rate (P = 0.18) were similar in the two groups. Radiographically, OLIF was more effective in restoring disc height (P = 0.01) and equivalent in improving the disc angle (P = 0.18) and lumbar lordosis (P = 0.48) compared with MIS-TLIF. The fusion rate (P = 0.11) was similar in both groups, while the subsidence was more severe in the MIS-TLIF group (P < 0.00001).ConclusionsThe above evidence suggests that OLIF is associated with a shorter operation time (with supplementary fixation in the prone position) and less intraoperative blood loss than MIS-TLIF and can lead to better leg pain alleviation, disc height restoration and subsidence resistance. No differences regarding back pain relief, functional recovery, complications, disc angle restoration, lumbar lordosis restoration and fusion rate were found. However, due to the limited number of studies, our results should be confirmed with high-level studies to fully compare the therapeutic efficacy of MIS-TLIF and OLIF.Trial registrationPROSPERO ID: CRD42020201903 .

Project description:BackgroundThe previous studies agree that minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) has better function outcomes, less blood loss, and shorter hospital stay, when compared to open-TLIF. However, there are no significance differences on operative time, complication, and reoperation rate between the two procedures. This could be from less relative literatures and lower grade evidence. The further meta-analysis is needed with more and higher grade evidences to compare the above two TLIF procedures.MethodsProspective and retrospective studies that compared open-TLIF and MIS-TLIF were identified by searching the Medline, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang, and VIP database (the literature search comprised Medical Subject Heading terms and key words or Emtree term). The retrieval time ranged from the date when the database was founded to January 2015. Pooled risk ratios (RR s) and weighted mean differences (WMDs) with 95% confidence intervals were calculated for the clinical outcomes and perioperative data.ResultsTwenty-four studies (n = 1967 patients) were included in this review (n = 951, open-TLIF, n = 1016, MIS-TLIF). MIS-TLIF was associated with a significant decrease in the visual analog score (VAS)-back pain score (WMD = -0.44; P = 0.001), Oswestry Disabilities Index (WMD = -1.57; P = 0.005), early ambulation (WMD = -1.77; P = 0.0001), less blood loss (WMD = -265.59; P < 0.00001), and a shorter hospital stay (WMD = -1.89; P < 0.0001). However, there were no significant differences in the fusion rate (RR = 0.99; P = 0.34), VAS-leg pain (WMD = -0.10; P = 0.26), complication rate (RR = 0.84; P = 0.35), operation time (WMD = -5.23; P = 0.82), or reoperation rate (RR = 0.73; P = 0.32).ConclusionsMIS-TLIF resulted in a similar fusion rate with better functional outcome, less blood loss, shorter ambulation, and hospital stay; furthermore, it did not increase the complication or reoperation rate based on the existing evidence.

Project description:ObjectiveTo compare the early radiographic and clinical outcomes of expandable uniplanar versus biplanar interbody cages used for single-level minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF).MethodsA retrospective review of 1-level MIS-TLIFs performed with uniplanar and biplanar polyetheretherketone cages was performed. Radiographic measurements were performed on radiographs taken preoperatively, at 6-week follow-up, and 1-year follow-up. Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg at 3-month and 1-year follow-up.ResultsA total of 93 patients (41 uniplanar, 52 biplanar) were included. Both cage types provided significant postoperative improvements in anterior disc height, posterior disc height, and segmental lordosis at 1 year. No significant differences in cage subsidence rates were found between uniplanar (21.9%) and biplanar devices (32.7%) at 6 weeks (odds ratio, 2.015; 95% confidence interval, 0.651-6.235; p = 0.249) with no additional instances of subsidence at 1 year. No significant differences in the magnitude of improvements based on ODI, VAS back, or VAS leg at 3-month or 1-year follow-up between groups and the proportion of patients achieving the minimal clinically important difference in ODI, VAS back, or VAS leg at 1 year were not statistically significantly different (p > 0.05). Finally, there were no significant differences in complication rates (p = 0.283), 90-day readmission rates (p = 1.00), revision surgical procedures (p = 0.423), or fusion rates at 1 year (p = 0.457) between groups.ConclusionBiplanar and uniplanar expandable cages offer a safe and effective means of improving anterior disc height, posterior disc height, segmental lordosis, and patient-reported outcome measures at 1 year postoperatively. No significant differences in radiographic outcomes, subsidence rates, mean subsidence distance, 1-year patient-reported outcomes, and postoperative complications were noted between groups.

Dataset Information

Surgical data and early postoperative outcomes after minimally invasive lumbar interbody fusion: results of a prospective, multicenter, observational data-monitored study.

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Surgical data and early postoperative outcomes after minimally invasive lumbar interbody fusion: results of a prospective, multicenter, observational data-monitored study.

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