Utility of minimum clinically important difference in assessing pain, disability, and health state after transforaminal lumbar interbody fusion for degenerative lumbar spondylolisthesis

2011 ◽  
Vol 14 (5) ◽  
pp. 598-604 ◽  
Author(s):  
Scott L. Parker ◽  
Owoicho Adogwa ◽  
Alexandra R. Paul ◽  
William N. Anderson ◽  
Oran Aaronson ◽  
...  
Keyword(s):  
Operating Characteristic ◽  
Interbody Fusion ◽  
Characteristic Curve ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Minimum Clinically Important Difference ◽  
Leg Pain ◽  
Sf 36 ◽  
Degenerative Lumbar Spondylolisthesis ◽  
The Mean ◽  
Lumbar Spondylolisthesis

Object Outcome studies for spine surgery rely on patient-reported outcomes (PROs) to assess treatment effects. Commonly used health-related quality-of-life questionnaires include the following scales: back pain and leg pain visual analog scale (BP-VAS and LP-VAS); the Oswestry Disability Index (ODI); and the EuroQol-5D health survey (EQ-5D). A shortcoming of these questionnaires is that their numerical scores lack a direct meaning or clinical significance. Because of this, the concept of the minimum clinically important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment effects reaching the MCID threshold value imply clinical significance and justification for implementation into clinical practice. Methods In 45 consecutive patients undergoing transforaminal lumbar interbody fusion (TLIF) for low-grade degenerative lumbar spondylolisthesis-associated back and leg pain, PRO questionnaires measuring BP-VAS, LPVAS, ODI, and EQ-5D were administered preoperatively and at 2 years postoperatively, and 2-year change scores were calculated. Four established anchor-based MCID calculation methods were used to calculate MCID, as follows: 1) average change; 2) minimum detectable change (MDC); 3) change difference; and 4) receiver operating characteristic curve analysis for two separate anchors (the health transition index [HTI] of the 36-Item Short Form Health Survey [SF-36], and the satisfaction index). Results All patients were available at the 2-year follow-up. The 2-year improvements in BP-VAS, LP-VAS, ODI, and EQ-5D scores were 4.3 ± 2.9, 3.8 ± 3.4, 19.5 ± 11.3, and 0.43 ± 0.44, respectively (mean ± SD). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS, 2.1–5.3; LP-VAS, 2.1–4.7; ODI, 11–22.9; and EQ-5D, 0.15–0.54). The mean area under the curve (AUC) for the receiver operating characteristic curve from the 4 PRO-specific calculations was greater for the HTI versus satisfaction anchor (HTI [AUC 0.73] vs satisfaction [AUC 0.69]), suggesting HTI as a more accurate anchor. Conclusions The TLIF-specific MCID is highly variable based on calculation technique. The MDC approach with the SF-36 HTI anchor appears to be most appropriate for calculating MCID because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was least affected by the choice of anchor. Based on the MDC method with HTI anchor, MCID scores following TLIF are 2.1 points for BP-VAS, 2.8 points for LP-VAS, 14.9 points for ODI, and 0.46 quality-adjusted life years for EQ-5D.

scholarly journals A Comparison of Minimally Invasive Transforaminal Lumbar Interbody Fusion and Decompression Alone for Degenerative Lumbar Spondylolisthesis

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Andrew Kai-Hong Chan ◽  
Erica F Bisson ◽  
Mohamad Bydon ◽  
Steven D Glassman ◽  
Kevin T Foley ◽  
...  
Keyword(s):  
Back Pain ◽  
Minimally Invasive ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Reoperation Rate ◽  
Leg Pain ◽  
Lumbar Interbody Fusion ◽  
Degenerative Lumbar Spondylolisthesis ◽  
Lumbar Spondylolisthesis

Abstract INTRODUCTION The optimal minimally invasive surgical (MIS) approach for lumbar spondylolisthesis is not clearly elucidated. This study compares patient reported outcomes (PRO) following MIS transforaminal lumbar interbody fusion (MI-TLIF) and MIS decompression for degenerative lumbar spondylolisthesis. METHODS A total of 608 patients from the Quality Outcomes Database (QOD) Lumbar Spondylolisthesis Module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis of whom 143 underwent MIS [72 MI-TLIF (50.3%) and 71 MIS decompressions (49.7%)]. Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse-plane MIS intervertebral body graft (MI-TLIF) or if there was a tubular decompression (MIS decompression). In total, 24-mo follow-up parameters were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) Back Pain, NRS Leg Pain, EuroQoL-5D (EQ-5D) Questionnaire, and North American Spine Society (NASS) Satisfaction Questionnaire. Multivariate models were constructed adjusting for baseline patient and surgical factors. RESULTS The mean age of the MIS cohort was 67.1 ± 11.3 yr (MI-TLIF 62.1 yr vs MIS decompression 72.3 yr) and consisted of 79 (55.2%) women (MI-TLIF 55.6% vs MIS decompression 54.9%). The proportions reaching 24-mo follow-up were similar (MI-TLIF 83.3% and MIS decompression 84.5%; P = .85). MI-TLIF was associated with higher blood loss (108.8 vs 33.0 mL, P < .001), longer operative times (228.2 vs 101.8 min, P < .001) and length of hospitalization (2.9 vs 0.7 d, P < .001). MI-TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, P = .004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 mo (P < .001). In multivariate analyses, MI-TLIF was associated with superior ODI change (ß = −7.59; 95% CI [−14.96 to −0.23]; P = .04), NRS back pain change (ß = −1.54; 95% CI [−2.78 to −0.30]; P = .02), and NASS satisfaction (OR = 0.32; 95% CI [0.12-0.82]; P = .02). CONCLUSION For symptomatic, single-level degenerative spondylolisthesis, MI-TLIF was associated with a 10-fold lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared to MIS decompression alone.

scholarly journals A comparison of minimally invasive transforaminal lumbar interbody fusion and decompression alone for degenerative lumbar spondylolisthesis

2019 ◽  
Vol 46 (5) ◽  
pp. E13 ◽  
Author(s):  
Andrew K. Chan ◽  
Erica F. Bisson ◽  
Mohamad Bydon ◽  
Steven D. Glassman ◽  
Kevin T. Foley ◽  
...  
Keyword(s):  
Back Pain ◽  
Minimally Invasive ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Reoperation Rate ◽  
Leg Pain ◽  
Lumbar Interbody Fusion ◽  
Degenerative Lumbar Spondylolisthesis ◽  
Lumbar Spondylolisthesis

OBJECTIVEThe optimal minimally invasive surgery (MIS) approach for grade 1 lumbar spondylolisthesis is not clearly elucidated. In this study, the authors compared the 24-month patient-reported outcomes (PROs) after MIS transforaminal lumbar interbody fusion (TLIF) and MIS decompression for degenerative lumbar spondylolisthesis.METHODSA total of 608 patients from 12 high-enrolling sites participating in the Quality Outcomes Database (QOD) lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis, of whom 143 underwent MIS (72 MIS TLIF [50.3%] and 71 MIS decompression [49.7%]). Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse plane MIS intervertebral body graft (MIS TLIF) or if there was a tubular decompression (MIS decompression). Parameters obtained at baseline through at least 24 months of follow-up were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back pain, NRS for leg pain, EuroQol-5D (EQ-5D) questionnaire, and North American Spine Society (NASS) satisfaction questionnaire. Multivariate models were constructed to adjust for patient characteristics, surgical variables, and baseline PRO values.RESULTSThe mean age of the MIS cohort was 67.1 ± 11.3 years (MIS TLIF 62.1 years vs MIS decompression 72.3 years) and consisted of 79 (55.2%) women (MIS TLIF 55.6% vs MIS decompression 54.9%). The proportion in each cohort reaching the 24-month follow-up did not differ significantly between the cohorts (MIS TLIF 83.3% and MIS decompression 84.5%, p = 0.85). MIS TLIF was associated with greater blood loss (mean 108.8 vs 33.0 ml, p < 0.001), longer operative time (mean 228.2 vs 101.8 minutes, p < 0.001), and longer length of hospitalization (mean 2.9 vs 0.7 days, p < 0.001). MIS TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, p = 0.004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 months (p < 0.001, all comparisons relative to baseline). In multivariate analyses, MIS TLIF—as opposed to MIS decompression alone—was associated with superior ODI change (β = −7.59, 95% CI −14.96 to −0.23; p = 0.04), NRS back pain change (β = −1.54, 95% CI −2.78 to −0.30; p = 0.02), and NASS satisfaction (OR 0.32, 95% CI 0.12–0.82; p = 0.02).CONCLUSIONSFor symptomatic, single-level degenerative spondylolisthesis, MIS TLIF was associated with a lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared with posterior MIS decompression alone. This finding may aid surgical decision-making when considering MIS for degenerative lumbar spondylolisthesis.

A Comparison of Minimally Invasive and Open Transforaminal Lumbar Interbody Fusion for Grade 1 Degenerative Lumbar Spondylolisthesis: An Analysis of the Prospective Quality Outcomes Database

Neurosurgery ◽  
2020 ◽  
Vol 87 (3) ◽  
pp. 555-562 ◽  
Author(s):  
Andrew K Chan ◽  
Erica F Bisson ◽  
Mohamad Bydon ◽  
Kevin T Foley ◽  
Steven D Glassman ◽  
...  
Keyword(s):  
Blood Loss ◽  
Minimally Invasive ◽  
Sample Size ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Small Sample ◽  
Lumbar Interbody Fusion ◽  
Quality Outcomes ◽  
Degenerative Lumbar Spondylolisthesis ◽  
Lumbar Spondylolisthesis

ABSTRACT BACKGROUND It remains unclear if minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is comparable to traditional, open TLIF because of the limitations of the prior small-sample-size, single-center studies reporting comparative effectiveness. OBJECTIVE To compare MI-TLIF to traditional, open TLIF for grade 1 degenerative lumbar spondylolisthesis in the largest study to date by sample size. METHODS We utilized the prospective Quality Outcomes Database registry and queried patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery with MI- or open TLIF methods. Outcomes were compared 24 mo postoperatively. RESULTS A total of 297 patients were included: 72 (24.2%) MI-TLIF and 225 (75.8%) open TLIF. MI-TLIF surgeries had lower mean body mass indexes (29.5 ± 5.1 vs 31.3 ± 7.0, P = .0497) and more worker's compensation cases (11.1% vs 1.3%, P &lt; .001) but were otherwise similar. MI-TLIF had less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 mL, P &lt; .001), longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 min, P &lt; .001), and a higher return-to-work (RTW) rate (100% vs 80%, P = .02). Both cohorts improved significantly from baseline for 24-mo Oswestry Disability Index (ODI), Numeric Rating Scale back pain (NRS-BP), NRS leg pain (NRS-LP), and Euro-Qol-5 dimension (EQ-5D) (P &gt; .001). In multivariable adjusted analyses, MI-TLIF was associated with lower ODI (β = −4.7; 95% CI = −9.3 to −0.04; P = .048), higher EQ-5D (β = 0.06; 95% CI = 0.01-0.11; P = .02), and higher satisfaction (odds ratio for North American Spine Society [NASS] 1/2 = 3.9; 95% CI = 1.4-14.3; P = .02). Though trends favoring MI-TLIF were evident for NRS-BP (P = .06), NRS-LP (P = .07), and reoperation rate (P = .13), these results did not reach statistical significance. CONCLUSION For single-level grade 1 degenerative lumbar spondylolisthesis, MI-TLIF was associated with less disability, higher quality of life, and higher patient satisfaction compared with traditional, open TLIF. MI-TLIF was associated with higher rates of RTW, less blood loss, but longer operative times. Though we utilized multivariable adjusted analyses, these findings may be susceptible to selection bias.

scholarly journals Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion Provides Sustained Improvements in Clinical and Radiological Outcomes up to 5 Years Postoperatively in Patients with Neurogenic Symptoms Secondary to Spondylolisthesis

2017 ◽  
Vol 11 (2) ◽  
pp. 204-212 ◽  
Author(s):  
Hamid Rahmatullah Bin Abd Razak ◽  
Priyesh Dhoke ◽  
Kae-Sian Tay ◽  
William Yeo ◽  
Wai-Mun Yue
Keyword(s):  
Minimally Invasive ◽  
Interbody Fusion ◽  
Short Form ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Adjacent Segment ◽  
Lumbar Interbody Fusion ◽  
Single Level ◽  
Sf 36 ◽  
Cage Subsidence ◽  
The Mean

<sec><title>Study Design</title><p>Retrospective review of prospective registry data.</p></sec><sec><title>Purpose</title><p>To determine 5-year clinical and radiological outcomes of single-level instrumented minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) in patients with neurogenic symptoms secondary to spondylolisthesis.</p></sec><sec><title>Overview of Literature</title><p>MIS-TLIF and open approaches have been shown to yield comparable outcomes. This is the first study to assess MIS-TLIF outcomes using the minimal clinically important difference (MCID) criterion.</p></sec><sec><title>Methods</title><p>The outcomes of 56 patients treated by a single surgeon, including the Oswestry disability index (ODI), neurogenic symptom score, short-form 36 questionnaire (SF-36), and visual analog scale (VAS) scores for back pain (BP), and leg pain (LP), were collected prospectively for up to 5 years postoperatively. Radiological outcomes included adjacent segment degeneration, fusion, cage subsidence, and screw loosening rates.</p></sec><sec><title>Results</title><p>Our patients were predominantly female (71.4%) and had a mean age of 53.7±11.3 years and mean body mass index of 25.7±3.7 kg/m<sup>2</sup>. The mean operative time, blood loss, time to ambulation, and hospitalization were 167±49 minutes, 126±107 mL, 1.2±0.4 days, and 2.8±1.1 days, respectively. The mean fluoroscopic time was 58.4±33 seconds, and the mean postoperative intravenous morphine dose was 8±2 mg. Regarding outcomes, postoperative scores improved relative to preoperative scores, and this was sustained across various time points for up to 5 years (<italic>p</italic>&lt;0.001). Improvements in ODI, SF-36, VAS-BP, and VAS-LP all met the MCID criterion. Notably, 5.4% of our patients developed clinically significant adjacent segment disease during follow-up, and 7 minor complications were reported.</p></sec><sec><title>Conclusions</title><p>Single-level instrumented MIS-TLIF is suitable for patients with neurogenic symptoms secondary to lumbar spondylolisthesis and is associated with an acceptable complication rate. Both clinical and radiological outcomes were sustained up to 5 years postoperatively, with many patients achieving an MCID.</p></sec>

scholarly journals A Comparison of Minimally Invasive and Open Transforaminal Lumbar Interbody Fusion for Grade 1 Degenerative Lumbar Spondylolisthesis: An Analysis of the Prospective Quality Outcomes Database

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Andrew Kai-Hong Chan ◽  
Erica F Bisson ◽  
Mohamad Bydon ◽  
Steven D Glassman ◽  
Kevin T Foley ◽  
...  
Keyword(s):  
Blood Loss ◽  
Minimally Invasive ◽  
Interbody Fusion ◽  
Statistical Significance ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Home Healthcare ◽  
Lumbar Interbody Fusion ◽  
Quality Outcomes ◽  
Degenerative Lumbar Spondylolisthesis ◽  
Lumbar Spondylolisthesis

Abstract INTRODUCTION Here, we compare minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) to traditional, open TLIF for grade 1 degenerative lumbar spondylolisthesis in the largest study to date by sample size. METHODS We utilized the multicenter, prospective Quality Outcomes Database registry and queried patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery with fully minimally invasive or open TLIF methods. Outcomes were compared 24 mo postoperatively: Oswestry Disability Index (ODI), Numeric Rating Scale Back Pain (NRS-BP), NRS Leg Pain (NRS-LP), EuroQol-5D (EQ-5D), North American Spine Society (NASS) Satisfaction Score, cumulative reoperation rate, and return to work (RTW) rate. Multivariate analyses were utilized to adjust for variables reaching P < .20 on univariate analyses. RESULTS A total of 297 patients were included: 72 (24.2%) MI-TLIF and 225 (75.8%) open TLIF. Average age (MI-TLIF: 62.1 vs open TLIF: 59.5 yr) was similar (P = .10). MI-TLIF surgeries were associated with lower body mass index (29.5 ± 5.1 vs 31.3 ± 7.0, P = .0497) and more workman's compensation cases (11.1% vs 1.3%, P = .001). Patients did not differ significantly at baseline for ODI, NRS BP, NRS LP and EQ-5D (P > .05). MI-TLIF was associated with less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 mL, P < .001), longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 min, P < .001), and a trend toward decreased length of hospitalization (2.9 ± 1.8 vs 3.3 ± 1.6 d, P = 0.08). Discharge disposition to home or home healthcare was similar (94.4% vs 91.1%, P = .38). Both cohorts improved significantly from baseline for 24-month ODI, NRS-BP, NRS-LP, and EQ-5D (P > .001). In adjusted analyses, MI-TLIF was associated with superior ODI (ß = −4.7; 95% CI-9.3 −0.04; P = .048) and EQ-5D (ß = 0.06; 95% CI 0.009-0.11; P = .02). Though trends for superiority were evident for MI-TLIF, they did not reach statistical significance for NRS-BP (P = .06), NRS-LP (P = .07), and NASS Satisfaction (P = .06). Similarly, there was a trend for fewer reoperations following MI-TLIF, though this did not reach statistical significance (1.4% vs 7.6%, P = .10). A higher proportion of MI-TLIF patients were able to RTW following surgery (100% vs 80%, P = .02). CONCLUSION For single-level grade 1 degenerative lumbar spondylolisthesis, MI-TLIF was associated with superior outcomes for disability and quality of life compared with traditional, open TLIF. MI-TLIF was associated with higher rates of RTW and less blood loss, but longer operative times.

Lumbar alignment and patient-reported outcomes after single-level transforaminal lumbar interbody fusion for degenerative lumbar spondylolisthesis with and without local coronal imbalance

2020 ◽  
pp. 1-7
Author(s):  
Wei Pan ◽  
Jia-li Zhao ◽  
Jin Xu ◽  
Ming Zhang ◽  
Tao Fang ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Coronal Alignment ◽  
Distinct Subgroup ◽  
Coronal Imbalance ◽  
Degenerative Lumbar Spondylolisthesis ◽  
Patient Reported ◽  
Lumbar Spondylolisthesis ◽  
Lumbar Alignment

OBJECTIVEThe purpose of this study was to compare the preoperative radiographic features of degenerative lumbar spondylolisthesis (DLS) with and without local coronal imbalance (LCI) and to investigate the surgical outcomes of transforaminal lumbar interbody fusion (TLIF) in the treatment of DLS with LCI at the spondylolisthesis level. DLS with scoliotic disc wedging and/or lateral listhesis at the same involved segment, as well as LCI, constitutes a distinct subgroup. However, previous studies concerning surgical outcomes focused mainly on sagittal profiles. There is a paucity of valid data regarding lumbar coronal alignment and patient-reported outcomes (PROs) after surgery in DLS with LCI.METHODSThe authors reviewed consecutive patients who received TLIF for L4/5 DLS between 2009 and 2018. Patients were assigned to the LCI and non-LCI groups based on preoperative radiographs. Demographics, radiographic parameters related to both sagittal and coronal alignment, and PROs were compared between the 2 groups.RESULTSThere were 21 patients in the LCI and 80 in the non-LCI group. Compared with the non-LCI group, the LCI group was characterized by lower preoperative lumbar lordosis on sagittal alignment (38.3° vs 43.7°, p < 0.05), higher lumbar Cobb angle on coronal alignment (12.4° vs 5.1°, p < 0.05), and worse lumbar coronal balance (18.5 mm vs 6.8 mm, p < 0.05). After surgery, lumbar alignment in the sagittal and coronal planes was significantly improved in the LCI group, whereas no significant changes occurred in the non-LCI group. Scores on the preoperative Oswestry Disability Index and the visual analog scale for back pain and leg pain scores were significantly higher in the LCI group, whereas no differences were found between the 2 groups in the postoperative evaluation (p > 0.05).CONCLUSIONSDLS with LCI constitutes a distinct subgroup characterized by coronal malalignment and loss of whole lumbar lordosis, which may result in worse PROs. The TLIF procedure allows the reconstruction of the coronal and sagittal lumbar profile and achievement of satisfactory PROs.

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