P-15 Peptide Enhanced Bone Graft Improves Time to Fusion in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study.

Prospective, multicenter, single-blind, randomized, controlled pivotal study. To evaluate whether P-15L (PearlMatrix TM P-15 Peptide Enhanced Bone Graft) is non-inferior in effectiveness to local autograft when applied in single level instrumented transforaminal lumbar interbody fusion (TLIF). P-15L, an FDA-designated Breakthrough Drug-Device, is a composite drug-device combination bone graft containing P-15, a 15-amino acid polypeptide, which enhances cell binding, proliferation, and differentiation resulting in bone formation. Skeletally mature patients, aged 22-80 years, with degenerative disc disease (DDD) were randomized 1:1 to P-15L (investigational) or to the local autograft (control) during single-level TLIF with a polyetheretherketone (PEEK) cage and supplemental pedicle screw fixation. The primary outcome was Composite Clinical Success (CCS) at 24 months, defined as: no index level secondary surgical procedures; achievement of fusion; ≥15-point improvement in Oswestry Low Back Pain Disability Questionnaire (ODI) from baseline; no new or worsening persistent neurological deficit relative to baseline; and no device-related serious adverse events (SAEs). 290 patients were enrolled at 33 sites: 141 (48.6%) received P-15L, and 149 (51.3%) received local autograft. P-15L was non-inferior ( P <0.0001) and superior ( P =0.002) to autograft with respect to CCS, with 55.5% of the investigational group achieving composite clinical success compared with 37.5% of the control group. P-15L had a 25.8% higher fusion rate as compared to autograft for the CCS at 24 months (84.3% vs. 58.5%, respectively). Device-related SAE rates were similar in both groups. P-15L was superior to local autograft in achieving clinical success at 24 months. Furthermore, P-15L produced a significantly higher fusion rate as compared to autograft. No meaningful clinical differences were found in the incidence of device-related SAEs. P-15L appears to be a safe and effective option for TLIF. 1.

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.

This review seeks to investigate the clinically relevant bone graft materials in single-level transforaminal lumbar interbody fusion (TLIF) procedures as defined by (1) primary outcomes (ie, fusion rates and complication rates) and (2) patient-reported outcomes (ie, visual analog scale [VAS] and Oswestry disability index [ODI]). Because of the advantages in stimulating bone growth, autologous bone grafts such as the iliac crest bone graft (ICBG) have been the gold standard. Numerous alternatives to ICBG have been introduced. Understanding the risks and benefits of bone graft options is vital to optimizing patient care. A PubMed search was performed for all clinical studies published between January 2008 and March 2023 that referenced the single-level TLIF procedure as well as one of the following grafts: autograft, allograft, bone morphogenetic protein (BMP), demineralized bone matrix, or mesenchymal stem cells (MSCs). Case studies and reports were excluded. Twenty-eight studies met the inclusion criteria. Studies from the PubMed search demonstrated similarly high fusion rates across nearly all graft materials, the lone exception being MSCs, which showed lower fusion rates. ICBG grafts experienced higher rates of postoperative graft site pain. The BMP graft material had high rates of radiculitis, heterogeneous ossification, and vertebral osteolysis. Patients saw an overall improvement in VAS and ODI scores with all graft materials. Local autografts and ICBG have been the most studied. Fusion rates during single-level TLIF were similar across all graft materials except MSCs. Patient-reported pain levels improved after TLIF surgery regardless of the type of grafts used. While BMP implants have shown promising benefits, they have introduced a new array of complications not normally seen in ICBG implants. The study is limited by the lack of evidence of certain graft materials as well as nonuniformity in metrics evaluating the efficacy of graft materials.

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.

Stand-alone ALIF versus TLIF in patients with low back pain – A propensity-matched cohort study with two-year follow-up

The purpose of this study was to analyze the surgical outcomes in cases involving elderly patients who underwent single-level instrumented mini-open transforaminal lumbar interbody fusion (TLIF). The authors performed a retrospective review of 27 consecutive cases involving elderly patients (> or = 65 years of age) who underwent single-level instrumented mini-open TLIF and were followed up for at least 3 years. Degenerative spondylolisthesis was diagnosed in 16 patients, stenosis with instability in 8, and lytic spondylolisthesis in 3. All cases were Grade I or II based on the American Society of Anesthesiologists' classification system. Clinical outcomes were assessed using a visual analog scale, the Oswestry Disability Index, and patients' subjective satisfaction. Sagittal balance, bone union, and adjacent segment degeneration (ASD) were assessed using plain radiography and 3D CT. The mean age of patients at the time of surgery was 69.3 years (range 65-80 years). Minor complications occurred in 2 patients (7.4%) in the perioperative period. At a mean follow-up duration of 38.6 months (range 36-42 months), clinical success was achieved in 88.9% of cases. The mean segmental lordosis and sacral tilt significantly increased after surgery (from 11.9 and 33.5 degrees to 13.9 and 37.2 degrees , p = 0.024 and p = 0.001, respectively). Solid fusion was achieved in 77.8% of the patients. Adjacent segment deterioration was found in 44.4% of the patients. No patients underwent revision surgery due to nonunion or ASD. The development of ASD was significantly related to postoperative sacral tilt (p = 0.006). Single-level instrumented mini-open TLIF yielded good clinical and radiological outcomes with a low complication rate in elderly patients.

Objective To compare the radiographic and clinical results of transforaminal lumbar interbody fusion(TLIF) in the treatment of degenerative spondylolisthesis (DS) with or without kyphotic angulation. Methods This study retrospectively reviewed a consecutive cohort of 137 patients with L4 DS (Meyerding grade I or II) who received TLIF between January 2009 and December 2012 and had a minimum follow-up of 2 years, including 24 males and 113 females, with the average age of 59.1±11.6 years (45-72 years) . The enrolled patients were divided into two groups based on the angulation of intervertebral space: the kyphotic group and the non-kyphotic group. Slip angle (SA), anterior disc height (ADH), posterior disc height (PDH), slip percentage (SP) and segmental kyphosis (SK) was measured to evaluate the radiographic outcomes. Oswestry disability index (ODI) and visual analogue scale (VAS) was collected to evaluate the clinical results. The radiographic measurements and clinical indexes were recorded before and after surgery and at latest follow-up. The independent samples t test was performed to analyze the differences between the two groups in terms of radiographic and clinical outcomes. Results Kyphotic slip was observed in 21(15.3%) patients, while non-kyphotic slip in 116 (84.7%) patients. No significant difference was observed in terms of age, gender, operation time and blood loss between the two groups. The preoperative SA in kyphotic and non-kyphotic group was 3.1°±2.3° and -8.2°±4.7°, respectively. The kyphotic group had significantly lower ADH and higher PDH than the non-kyphotic group, while there was no significant difference in SP between the two groups. After surgery, the postoperative and latest follow up radiographic results showed that patients of both groups had significant improvement, without significant differences between groups in terms of ADH, PDH, SA and SK, but the reduction of slip was significantly higher in the kyphotic group. Postoperative and follow-up ODI and VAS scores demonstrated remarkable improvement after surgery, without difference between groups, despite being higher in the kyphotic group than the non-kyphotic group preoperatively. Conclusion The kyphotic angulation of intervertebral space benefits to and facilitates slip reduction for L 4 DS via TLIF procedure, and achieves improvements in life quality which is similar to the nonkyphotic group. Key words: Lumbar vertebrae; Intervertebral disc degeneration; Spondylolysis; Spinal fusion; Quality of life

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

To investigate the effectiveness of modified direction-changeable lumbar Cage in transforaminal lumbar interbody fusion (TLIF). A retrospective analysis was made of 161 patients with single segment L 4 or L 5 isthmic spondylolisthesis treated between January 2013 and December 2015. According to the implantation of Cage, they were divided into trial group (85 cases, modified direction-changeable lumbar Cage implanted in TLIF) and control group (76 cases, traditional nondirection-changeable Cage implanted in TLIF). There was no significant difference in the general data of gender, age, disease duration, slippage segment, and slippage grade between the two groups ( P>0.05). The intraoperative implantation time of Cage, Cage position adjustments times, fluoroscopy times during implantation of Cage, fluoroscopy exposure time, and total operation time were recorded and compared between the two groups. Visual analogue scale (VAS) and Oswestry disability index (ODI) scores were used to evaluate the effectiveness of the patients before operation, and at 3, 6, and 12 months after operation, and the incidence of complications was recorded and analyzed. CT examinations were performed at 6 and 12 months after operation, and lumbar fusion was evaluated by Bridwell criteria. The intraoperative implantation time of Cage, Cage position adjustments times, fluoroscopy times during implantation of Cage, fluoroscopy exposure time, and total operation time in trial group were significant less than those in control group ( P<0.05). All the 161 patients were followed up 12-18 months (mean, 14.3 months). There was 1 case of dural sac tear in the trial group and 1 case of superficial infection in the control group; no complication such as dural tear and infection occurred in other patients. The fusion rate was 76.5% (64/85) in the trial group and 57.9% (44/76) in the control group at 6 months after operation, showing significant difference ( χ 2=6.44, P=0.02); at 12 months after operation, the fusion rate was 96.5% (82/85) in the trial group and 90.8% (69/76) in the control group (including 3 cases of Cage displacement and 4 cases of screw breakage), showing no significant difference in the fusion rate between the two groups ( χ 2=1.54, P=0.26). The VAS and ODI scores of the two groups decreased gradually at 3, 6, and 12 months after operation, and improved significantly when compared with those before operation ( P<0.05). There was no significant difference in VAS and ODI scores between the two groups before and after operation ( P>0.05). Both Cages can obtain the similar effectiveness. The modified direction-changeable lumbar Cage can significantly reduce the fluoroscopy times and radiation dose during TLIF, shorten the operation time, and effectively reduce the radiation exposure of patients and medical staff.

Allogeneic mesenchymal precursor cells treatment for chronic low back pain associated with degenerative disc disease: a prospective randomized, placebo-controlled 36-month study of safety and efficacy

BackgroundConventional open transforaminal lumbar interbody fusion (TLIF) using unilateral pedicle screws and a translaminar facet screw has been performed for many years with good results. The outcomes of minimally invasive TLIF (MIS TLIF) are similar to the good outcomes of open TLIF, with the additional benefits of reducing iatrogenic injury, shortening hospital stays, and reducing the recovery duration. Instead of using small cuts on both sides, we performed MIS TLIF through a single cut using unilateral pedicle screws and a translaminar facet screw. The operative feasibility, efficacy safety, and benefits of single-level MIS TLIF of such techniques require further clarification.MethodsA total of 60 patients with various single-segment lower lumbar vertebral diseases were treated in our department from January 2010 to March 2013. All the patients were initially performed single-level MIS TLIF using a hybrid construction of unilateral pedicle screws and a translaminar facet screw. Patient demographics and operative data were collected. The clinical outcomes were assessed before surgery and 3, 6, 12, and 24 months after surgery using the visual analog scale (VAS) for back and leg pain and the Oswestry Disability Index (ODI). Radiologic assessment of the lumbar spine with static and dynamic plain radiographs was performed 3, 6, 12, and 24 months after surgery. The fusion rates were assessed by an independent radiologist 2 years after surgery according to the Bridwell interbody fusion grading system.ResultsNo patients experienced significant postoperative complications. Excepting two cases, 58 cases were followed up for 24–38 months, averaged 29.9 ± 4.1 months. The patients’ average age was 46.6 ± 11.5 years, operative time 109.7 ± 17.8 min, intraoperative blood loss 67.3 ± 29.7 ml, length of incision 29.0 ± 3.2 mm, fluoroscopy time 31.1 ± 7.2 s, time to ambulation 20.3 ± 7.0 h, length of hospital stay 5.1 ± 1.1 days, and length of the translaminar facet screw 51.7 ± 3.4 mm. Screw position results: type I, 54 cases with 54 segments; type II, four cases with four segments. There were two (3.4%) translaminar facet screw failures, which were intraoperatively converted to a bilateral pedicle screw fixation procedure and excluded from the research. The postoperative images showed good positioning of the hybrid internal fixation, and all of the translaminar facet screws penetrated the facet joint. Two (3.6%) translaminar facet screws penetrated the lateral lamina and two (3.6%) translaminar facet screws penetrated the medial lamina without any serious neural complications. During the follow-up, there was no screw loosening or pedicle fracture observed. The VAS and ODI scores were significantly improved compared with the preoperative scores (P < 0.05), and the symptoms disappeared gradually. Fifty-one patients (87.9%) achieved grade I fusion radiographically at the final follow-up.ConclusionsMIS TLIF using a hybrid construction of unilateral pedicle screws and a translaminar facet screw is safe and effective in the treatment of single-segment lower lumbar vertebral disease, and it can be used as an optimal choice for fixation and fusion of some single-segment lower lumbar vertebral diseases.

Effect of Single-Level Transforaminal Lumbar Interbody Fusion on Segmental and Overall Lumbar Lordosis in Patients with Lumbar Degenerative Disease.

This is a meta-analysis and systematic review of the available literature. This study aims to compare the clinical and radiologic outcomes of single-level lateral lumbar interbody fusion (LLIF) with single-level transforaminal lumbar interbody fusion (TLIF). In the treatment of adult spinal deformity, LLIF allows interbody fusion while avoiding complications associated with an anterior or transforaminal approach, although the clinical outcomes of LLIF compared with other approaches have not been well established. We searched PubMed, Embase, and Scopus for 385 unique studies. On the basis of our exclusion criteria, 8 studies remained for our systematic review. Data were analyzed using Review Manager 5.3 using Mantel-Haenszel statistics and random effect models. This study identified self-reported Visual Analog Scale (VAS), Oswestry Disability Index, length of stay, blood loss, complication rate, and radiologic parameters (disk height, lumbar lordosis, segmental lordosis). Our meta-analysis showed that LLIF contributed to decreased blood loss [mean difference (MD)=-67.62 mL, 95% confidence interval (CI): -104 to -30.90, P<0.001], superior restoration of segmental lordosis (MD=1.91 degrees, 95% CI: 0.71-3.10, P=0.002), lumbar lordosis (MD=1.95 degrees, 95% CI: 0.15-3.74, P=0.03), and disk height (MD=2.18 mm, 95% CI: 1.18-3.17, P<0.001) when compared with TLIF. However, current data suggests no significant difference in clinical outcomes between LLIF and TLIF based on overall complication rates (P=0.22), length of hospital stay (P=0.65), postoperative Oswestry Disability Index (P=0.13), postoperative VAS Back Pain (P=0.47) and VAS Leg Pain (P=0.16). LLIF is an increasingly popular option for single-level anterior column reconstruction. When compared with single-level TLIF, single-level LLIF is associated with greater changes in lumbar lordosis and disk height. The single-level LLIF is a viable alternative to TLIF, demonstrating comparable clinical outcomes and better restoration of spinopelvic parameters. Level III.

Although gelatin-thrombin matrix sealants have been used successfully in other surgery types, their effect on reducing blood loss during single-level transforaminal lumbar interbody fusion is unclear. We thus examined the efficacy of gelatin-thrombin matrix sealants for reducing blood loss during such surgery. We analyzed 102 patients who underwent single-level transforaminal lumbar interbody fusion for lumbar degenerative disease. We compared body mass index, surgical time, intraoperative blood loss, postoperative blood loss, true total blood loss, hidden blood loss, the proportion of blood transfusion, blood pressure pre- and post-surgery (systolic and diastolic), and pre-and post-surgery laboratory data (hemoglobin, hematocrit, platelets, prothrombin time, activated partial thromboplastin time, and D-dimer) between patients in whom gelatin-thrombin matrix sealants were (GTMS group) or were not (control group) used during surgery. One-week postoperative epidural hematoma size was measured using magnetic resonance imaging. The GTMS and control groups included 54 (24 males and 30 females) and 48 patients (19 males and 29 females). Intraoperative, true total, and hidden blood loss; epidural hematoma size; and hospitalization duration were significantly lower in the GTMS than in the control group. Intraoperative blood loss correlated with surgical time (R = 0.523, P = .001), body mass index (R = 0.221, P = .036), and the amount of gelatin-thrombin matrix sealant used (r = -0.313, P = .002). In multivariate linear regression analysis using intraoperative blood loss as the dependent variable, surgical time (standardization coefficient 0.516, P = .001) and amount of gelatin-thrombin matrix sealant used (standardization coefficient -0.220, P = .032) were independently related factors. In our study, the GTMS group had significantly less intraoperative true total and hidden blood loss than did the control group. Thus, use of gelatin-thrombin matrix sealants reduce perioperative blood loss in transforaminal lumbar interbody fusion.