P-15 Peptide Enhanced Bone Graft in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study Demonstrating Improved Composite Clinical Success.

Prospective, multicenter, single-blind, randomized, controlled pivotal study. Compare time-to-fusion in patients treated with P-15L (PearlMatrix TM P-15 Peptide Enhanced Bone Graft) versus local autograft over 24 months and evaluate changes in pain and quality of life at 24 months relative to baseline. P-15L, an FDA-designated Breakthrough Device, is a composite bone graft with P-15, a 15-amino acid polypeptide that promotes cellular adhesion, proliferation, and differentiation to support bone formation. Patients (22-80y) with degenerative disc disease were randomized to the investigational (P-15L) or control (local autograft) group during single-level transforaminal lumbar interbody fusion (TLIF) with a PEEK cage and supplemental pedicle screw fixation. Fusion assessments occurred at 6, 12, and 24 months. Time-to-fusion was tested for superiority as compared to the control using Kaplan-Meier survival analysis. Back and leg pain were measured using the Visual Analog Scale (VAS) and quality of life was assessed using the Short Form Survey (SF-12). The analysis included 290 patients from 33 sites; 141 (48.6%) received P-15L and 149 (51.3%) received local autograft. At randomization, at least 1 risk factor for pseudoarthrosis (obesity, nicotine use, or diabetes) was reported in 58.9% (83/141) of the investigational group and 60.4% (90/149) of the control group. More patients in the investigational than the control group achieved fusion at 6 months (Kaplan-Meier fusion rates 57.6% vs 26.9%, respectively), 12 months (68.8% vs 41.5%, respectively), and 24 months (81.1% vs 54.9%, respectively). P-15L was statistically superior to autograft for time-to-fusion (hazard ratio=1.87, 95% CI: 1.47, 2.38; P <0.0001). There was marked improvement in VAS and SF-12 relative to baseline in both groups at 24 months. P-15L promotes statistically superior earlier time-to-fusion than local autograft in instrumented TLIF. Both treatments resulted in clinically meaningful improvements in pain and quality of life at 24 months. 1.

Purpose The aim of the present study was to evaluate the outcomes of transforaminal lumbar interbody fusion (TLIF) versus instrumented posterolateral fusion (PLF) in degenerative lumbar spine diseases. Method The study was approved by the local ethics committee, and a written consent was obtained for each subject. The study included 40 patients divided into 2 groups (A and B), group A included 20 patients and it was treated by transforaminal lumbar interbody fusion (TLIF) while group B included 20 patients and it was treated by posterolateral fusion (PLF). Patients were followed for a period of one year. Results Functional outcome was assessed using Modified Oswestry low back pain disability questionnaire (ODI score). There was a statistically significant difference between preoperative and one year postoperative ODI score in TLIF group and PLF group (P-value <0.001) but the difference between preoperative and one year postoperative ODI score in TLIF group was more than that of PLF group. There was no statistical significant difference between both groups regarding post operative complications and the process of disc fusion. Conclusion Although there was no important statistically significant differences between Transforaminal Lumbar Interbody fusion (TLIF) and PosteroLateral Fusion (PLF), however TLIF is superior to PLF as regards clinical and radiological outcome. So, our study suggests TLIF over PLF in treatment degenerative lumbar spine dieases.

Postoperative Opioid Use Following Single-Level Transforaminal Lumbar Interbody Fusion Compared with Posterolateral Lumbar Fusion

BackgroundContiguous double-level lumbar spondylolytic spondylolisthesis is an extremely rare condition. There is a paucity of data of lumbosacral deformity and sagittal spino-pelvic malalignment among these patients. Moreover, the effect of transforaminal lumbar interbody fusion (TLIF) on sagittal realignment still remains largely unknown. The aim of the study is to investigate the reconstruction of sagittal alignment and the improvement of clinical outcomes after posterior instrumented double-level or single-level TLIF.MethodsFrom January 2010 to September 2018, the records of patients with contiguous L4/5 and L5/S1 double-level spondylolytic spondylolisthesis were retrospectively reviewed. Patients who had undergone double-level or single-level TLIF and a minimum of 2 years’ follow-up were included. The slippage parameters and spino-pelvic parameters were measured preoperatively, postoperatively, and at the latest follow-up.ResultsA total of 58 patients (21 males and 37 females, mean age of 57.1 ± 6.9 years) were enrolled. Thirty-eight patients were treated with double-level TLIF and the remaining 20 with single-level TLIF (L4/5 in 14; L5/S1 in 6). After surgery, the spondylolisthesis was significantly reduced at both L4/5 and L5/S1 level (all P < 0.001). There was a significant reduction in pelvic tilt (P < 0.001) and a significant increase in sacral slope (P < 0.001). Significant increase in L4–S1 height (P < 0.001) and L4–S1 lordosis (P = 0.012) and decrease in L5 slope (P = 0.004) and L5 incidence (P = 0.001) were also observed. Compared to single-level TLIF, double-level TLIF increased L4–S1 height (P < 0.001) and L4–S1 lordosis (P < 0.001) and reduced L4-SVA (P = 0.007) and L5 incidence (P = 0.013) more obviously, and the sagittal balance was better corrected in double-level TLIF group (P = 0.006). Double-level TLIF group showed larger increase in VAS scores for low back pain. The incidence of implant-related complications was lower in the double-level group.ConclusionPosterior short-segment instrumented TLIF can bring favorable radiographic and clinical outcomes in patients with lumbosacral contiguous double-level spondylolytic spondylolisthesis. Double-level TLIF is more efficient to improve L4–S1 height, regional lumbar lordosis, and global sagittal balance.

Obesity and Clinical, Radiographic, and Surgical Outcomes After Minimally Invasive Single-Level Transforaminal versus Lateral Lumbar Interbody Fusion.

Consecutive case series with prospective data collection. To define and analyze the learning curve for minimally invasive transforaminal lumbar interbody fusion (TLIF). Minimally invasive TLIF using a unilateral approach has recently been gaining popularity because of its potential for minimizing soft-tissue damage and reducing recovery time. However, a steep learning curve has been described for surgeons first performing this technique. Eighty-six consecutive patients with degenerative lumbar diseases who were treated by TLIF were included in the study. Surgeries were performed using a tubular retractor, and a cage was inserted using a unilateral transforaminal approach by a single surgeon. The corresponding segments were fixed with percutaneous pedicle screws. Eighty-three patients were followed up for more than 1 year, and the average follow-up period was 25 months. Single-level TLIF was performed in 60 cases, single-level TLIF plus adjacent-level decompression was performed in 13 cases, and double-level TLIF was performed in 13 cases. Corrected operative time per level, operative blood loss, postoperative blood drainage, total blood loss, and ambulation recovery time were measured. Transfusion rates and complication incidence were also identified. Clinical results were assessed using the Oswestry Disability Index (ODI) and a visual analogue scale (VAS). The learning curve was assessed using a logarithmic curve-fit regression analysis. In the single-level TLIF group (n = 60), 22 patients were defined as the "early" group (among the first 30 cases of the series), and the subsequent 38 cases were defined as the "late" group for comparison. Corrected operative time gradually decreased as the series progressed, and an asymptote was reached after about 30 cases. ODI significantly decreased from an average of 24 at the preoperative stage to 10 at the final follow-up. Average VAS scores for lower back pain and radiating pain also significantly decreased from an average of 5.2 to 1.9 and 6.8 to 0.9, respectively. In the single-level TLIF series, operative time was significantly shorter in the late group (183 ± 23 min) than the early group (254 ± 44 min), and blood loss during the operation was significantly reduced in the late group (292 ± 280 mL) compared with the early group (508 ± 278 mL). Ambulation recovery time significantly decreased from 2.4 ± 0.6 days in the early group to 2.0 ± 0.5 in the late group. ODI and VAS scores for lower back pain and radiating pain did not differ between the 2 groups. Although it is not easy to master the minimally invasive TLIF technique, the surgeon's experience with this operation correlated with reduced operation time and blood loss during surgery. After the initial learning curve, this technique could be an effective and reliable option for the surgical treatment of lumbar degenerative disease.

Can a mixture of hydroxyapatite (HA) and autologous bone from decompression sites produce similar results when used for transforaminal lumbar interbody fusion (TLIF)? In the current literature, autologous iliac crest bone grafts (ICBGs) have been reported the gold standard for this procedure. Indeed, to date, no clinical data have confirmed that a mixture of equal volumes of HA and local autologous bone produce similar results in term of fusion as the same volume of autologous ICBG alone. Study design/setting This study was approved by the local ethics committee and completed in a prospective, randomized, single-blinded manner. The results of lumbar fusion using TLIF and different bone grafting materials were compared. Patient sample The patient sample included patients with spinal lumbar degenerative disease. Outcome measures The clinical outcome was determined using the Oswestry Low Back Pain Disability Questionnaire (ODI) and Visual Analog Scale (VAS). The radiological outcomes and fusion rates were determined with radiographs evaluated using the McAfee criteria and computed tomography (CT) data evaluated by the Williams criteria. Three blinded investigators (one radiologist and two orthopedic surgeons) assessed the data. The secondary variables included donor site morbidity. Methods The patients were admitted to our department for orthopedic surgery with degenerative lumbar pathologies (L2-S1) that required stabilization in one or two segments using a TLIF procedure. The patients were 18-80years old. Only those patients who had degenerative lumbar pathologies and agreed to be educated about the study were included. The patients were divided into the following two randomized groups: group A: TLIF procedure using autologous ICBGs alone; and group B: TLIF procedure using local bone from decompression site mixed with hydroxyapatite. Each group received equal graft volumes. The mixture in group B consisted of equal volumes of local autograft (5cc) and synthetic bone (5cc). A graft volume of 10cc was used at each fusion level. The patients were followed up at three appointments at 1.5, 6 and 12months postoperatively. Every patient received detailed education about the course of the study. Forty-eight patients finished the study (2 patients dropped out). The radiographic fusion rate did not significantly differ between the two groups. Based on the CT criteria, 83.3% of the patients showed fusion in both groups after 12months. Furthermore, 95.3% of the patients in group A and 91.7% of the patients in group B showed bony spondylodeses according to the radiographic criteria at the 12-month follow-up. The donor site morbidity consisted of one patient with a wound infection and one with a hematoma in group A and two patients with persistent pain in group B. Group A also included one patient with cage subsidence of 4mm and archived fusion after 12months. In group B, one patient had a pedicle screw breakage and achieved fusion after 6months. The clinical outcomes were similar between the two groups. In both groups, the VAS and ODI data improved during the follow-up period (p<0.05). No patients required additional surgeries. Both groups demonstrated equivalent clinical outcomes. HA and autologous bone from decompression sites can achieve similar fusion rates to those achieved with identical volumes of the gold standard autologous graft. The graft mixture can be used for one- or two-level lumbar spondylodeses to avoid donor site morbidity.

Cost analysis of anterior-posterior circumferential fusion and transforaminal lumbar interbody fusion

Thursday, September 27, 2018 1:05 PM–2:05 PM Lumbar Spine Surgery: What You Need to Know: 114. No difference in reoperation rates or outcomes for a two-level posterolateral fusion augmented with single- versus two-level transforaminal lumbar interbody fusion

INTRODUCTION The lumbosacral junction acts as a transition point between the mobile lumbar spine and the rigid pelvis. It is thereby susceptible to degenerative changes necessitating fusion at L5-S1. In this study, we compared radiographic outcomes observed from single-level anterior lumbar interbody fusion (ALIF) and transforaminal lumbar interbody fusion (TLIF) at this level. METHODS Retrospective review of single-level ALIF and TLIF with up to one level PSF at L5-S1 between May 2007 and October 2018 was undertaken. X-ray measurements were gathered for lumbar lordosis, segmental lordosis, pelvic tilt, sacral slope, pelvic incidence, pelvic incidence-lumbar lordosis mismatch, anterior/posterior disc height, and sagittal vertical axis. Computed tomography /magnetic resonance imaging was used to determine central canal area, sagittal diameter, foraminal height, and foraminal area. RESULTS A total of 47 ALIF patients and 50 TLIF patients were included. Patients averaged 53.7 ± 10.1 yr of age for ALIF and 49.4 ± 14.7 yr old for TLIF (P = .094) with significant differences (P = .0017) seen with gender as ALIF had 60.4% males and TLIF 70.0% females. Single-level ALIF led to significantly (P = .0010) more segmental lordosis (+5.75° ± 7.31°) than TLIF (+0.25° ± 6.55°), though differences in lumbar lordosis were not statistically significant (P = .52). ALIF significantly increased both anterior (+10.4 ± 4.32 mm vs +4.30 ± 3.55 mm; P &lt; .0001) and posterior disc height (+4.33 ± 3.32 mm vs + 2.98 ± 2.07 mm; P = .043) than TLIF. Changes in sagittal vertical axis also significantly differed (P = .030) with ALIF decreasing sagittal vertical axis by 17.8 ± 26.4 mm from +60.3 mm to + 42.5 mm, and TLIF increasing by 0.95 ± 25.8 mm from 39.9 mm to 40.9 mm. Pelvic tilt, sacral slope, pelvic incidence, pelvic incidence-lumbar lordosis mismatch had no significant differences. No statistically significant differences were observed with central canal area, sagittal diameter, foraminal height or foraminal area between ALIF and TLIF. CONCLUSION At L5-S1, the ALIF approach leads to increased segmental lordosis, disc height, while also decreasing sagittal vertical axis to a significant degree than TLIF. However, these two approaches were no different with regards to pelvic parameters and measures of central canal and foraminal decompression.

Analysis of a Unilateral Bridging Cage for Lumbar Interbody Fusion: 2-Year Clinical Results and Fusion Rate with a Focus on Subsidence

A retrospective review of prospectively collected registry data. (1) Examine functional outcomes of patients with postoperative sacral slope (SS)<30 degrees versus SS≥30 degrees after single-level transforaminal lumbar interbody fusion (TLIF) for degenerative spondylolisthesis (DS); (2) determine the factors associated with SS at the last follow-up. Few studies have examined the relationship between spinopelvic parameters and functional outcomes in patients with DS undergoing short-segment TLIF. Although SS of 30 degrees has been proposed as the ideal spinopelvic parameter for eliminating residual pain and disability in adult spinal deformity, the ideal value for DS remains unknown. Prospectively collected registry data of 63 patients who underwent single-level L4-L5 open TLIF with sagittal realignment for DS were reviewed. Pelvic incidence, lumbar lordosis (LL), pelvic tilt, SS, listhesis excursion, and Bridwell fusion grading were recorded. Patients were stratified into SS<30 degrees (n=26) or SS≥30 degrees (n=37) at the last follow-up. All patients were assessed preoperatively and postoperatively at 2 years. Receiver operating characteristics curve analysis was used to assess the relationship between expectation fulfillment and change in SS. Patients with SS≥30 degrees had significantly lower back pain at 2 years (P<0.04). There were no differences in leg pain or outcome scores (Oswestry Disability Index, Short-Form 36 Physical, and Mental Component Summaries), although there was a trend towards better outcomes and higher satisfaction/expectation fulfillment in patients with SS≥30 degrees. The SS≥30 degrees group had a higher preoperative LL (P=0.04) and SS (P<0.01). Preoperative SS was correlated with SS (R=0.71, P<0.01) and LL (R=0.51, P<0.01) at the last follow-up. The area under the curve for change in SS was 0.680 (95% confidence interval, 0.453-0.907) for predicting expectation fulfillment at 2 years. Patients with increased SS (≥30 degrees) experienced less back pain after short-segment lumbar fusion surgery. This was associated with increased LL postoperatively, indicating better sagittal balance.

The purpose of this study was to investigate the effect of intraoperative positions in single-level (L4–5) transforaminal lumbar interbody fusion (TLIF) on segmental and overall lumbar lordosis (LL) in patients with lumbar degenerative disease. Thirty-eight consecutive patients who had undergone single-segment (L4–5) TLIF with 0° polyetheretherketone (PEEK) cage and pedicle screw fixation were evaluated. Twenty patients underwent surgery on the four-poster type frame with hip flexion at 30° (Group I) and 18 patients were operated on a Jackson spinal table to adjust their hip flexion to 0° (Group II). Preoperative standing, intraoperative prone, and postoperative standing lateral radiographs were obtained in each patient. The overall and segmental LL were analyzed according to the position in which the patients were placed for their operation and results compared between Groups I and II. Intraoperative intervertebral segmental LL at L4–5 and L5–S1 was increased in Group II than in Group I, whereas postoperative intervertebral segmental LL at L4–5 (fused level) was increased LL. In Group I intraoperative intervertebral segmental LL at L4–5 did not achieve sufficient lordosis, whereas postoperative intervertebral segmental LL at L3–4 was increased. The overall spinal alignment was unaffected by the decreased segmental LL in the fused level owing to the compensation of the upper adjacent segments. The more the hip was extended intraoperatively, the more the segmental lordosis increased in the lower lumbar spine. Thus, selecting the appropriate surgical table and hip position are very important. Underachievement of segmental lordosis leads to the acceleration of upper adjacent segment load.

Recombinant human bone morphogenetic protein 2 (rhBMP-2, or BMP for short) is a popular biological product used in spine surgeries to promote fusion and avoid the morbidity associated with iliac crest autograft. BMP's effect on pseudarthrosis in transforaminal lumbar interbody fusion (TLIF) remains unknown. To assess the rates of pseudarthrosis in single-level TLIF with and without concurrent use of BMP. This was a retrospective cohort study conducted at a single academic institution. Adults undergoing primary single-level TLIF with a minimum of 1 year of clinical and radiographic follow-up were included. BMP use was determined by operative notes at index surgery. Non-BMP cases with iliac crest bone graft were excluded. Pseudarthrosis was determined using radiographic and clinical evaluation. Bivariate differences between groups were assessed by independent t test and χ 2 analyses, and perioperative characteristics were analyzed by multiple logistic regression. One hundred forty-eight single-level TLIF patients were included. The mean age was 59.3 years, and 52.0% were women. There were no demographic differences between patients who received BMP and those who did not. Pseudarthrosis rates in patients treated with BMP were 6.2% vs 7.5% in the no BMP group (P = 0.756). There was no difference in reoperation for pseudarthrosis between patients who received BMP (3.7%) vs those who did not receive BMP (7.5%, P = 0.314). Patients who underwent revision surgery for pseudarthrosis more commonly had diabetes with end-organ damage (revised 37.5% vs not revised 1.4%, P < 0.001). Multiple logistic regression analysis demonstrated no reduction in reoperation for pseudarthrosis related to BMP use (OR 0.2, 95% CI 0.1-3.7, P = 0.269). Diabetes with end-organ damage (OR 112.6,95% CI 5.7-2225.8, P = 0.002) increased the risk of reoperation for pseudarthrosis. BMP use did not reduce the rate of pseudarthrosis or the number of reoperations for pseudarthrosis in single-level TLIFs. Diabetes with end-organ damage was a significant risk factor for pseudarthrosis. BMP is frequently used "off-label" in transforaminal lumbar interbody fusion; however, little data exists to demonstrate its safety and efficacy in this procedure.

Minimally invasive (MI) transforaminal lumbar interbody fusion (TLIF) has proven to be effective in the treatment of spondylolisthesis and degenerative disc disease (DDD). Compared with the traditional open TLIF, the MI procedure has been associated with less blood loss, less postoperative pain, and a shorter hospital stay. However, it is uncertain whether the advantages of an MI TLIF also apply specifically to obese patients. This study was dedicated to evaluating whether obese patients reap the perioperative benefits similar to those seen in patients with normal body mass index (BMI) when undergoing MI TLIF. Obese patients-that is, those with a BMI of at least 30 kg/m(2)-who had undergone single-level TLIF were retrospectively identified and categorized according to BMI: Class I obesity, BMI 30.0-34.9 kg/m(2); Class II obesity, BMI 35.0-39.9 kg/m(2); or Class III obesity, BMI ≥ 40.0 kg/m(2). In each obesity class, patients were stratified by TLIF approach, that is, open versus MI. Perioperative outcomes, including intraoperative estimated blood loss (EBL), complications (overall, intraoperative, and 30-day postoperative), and hospital length of stay (LOS), were compared. The chi-square test, Fisher exact test, or 2-tailed Student t-test were used when appropriate. One hundred twenty-seven patients were included in the final analysis; 49 underwent open TLIF and 78 underwent MI TLIF. Sixty-one patients had Class I obesity (23 open and 38 MI TLIF); 45 patients, Class II (19 open and 26 MI); and 21 patients, Class III (7 open and 14 MI). Overall, mean EBL was 397.2 ml and mean hospital LOS was 3.7 days. Minimally invasive TLIF was associated with significantly less EBL and a shorter hospital stay than open TLIF when all patients were evaluated as a single cohort and within individual obesity classes. Overall, the complication rate was 18.1%. Minimally invasive TLIF was associated with a significantly lower total complication rate (11.5% MI vs 28.6% open) and intraoperative complication rate (3.8% MI vs 16.3% open) as compared with open TLIF. When stratified by obesity class, MI TLIF was still associated with lower rates of total and intraoperative complications. This effect was most profound and statistically significant in patients with Class III obesity (42.9% open vs 7.1% MI). Minimally invasive TLIF offers obese patients perioperative benefits similar to those seen in patients with normal BMI who undergo the same procedure. These benefits include less EBL, a shorter hospital stay, and potentially fewer complications compared with open TLIF. Additional large retrospective studies and randomized prospective studies are needed to verify these findings.