P-15 Peptide Enhanced Bone Graft Improves Time to Fusion in Transforaminal Lumbar Interbody Fusion

Prospective, multicenter, single-blind, randomized, controlled pivotal study. To evaluate whether P-15L (PearlMatrix P-15 Peptide Enhanced Bone Graft) is noninferior 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 to 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). A total of 290 patients were enrolled at 33 sites: 141 (48.6%) received P-15L, and 149 (51.3%) received local autograft. P-15L was noninferior ( 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 with 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 with 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. Level I.

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

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.

Background There are not enough reliable studies available in physiotherapy to determine the effects of spinal manipulative therapy added to exercise on thoracic spinal pain and quality of life. Objective To investigate the effects of spinal manipulation on pain and quality of life in subjects with thoracic spinal pain. Study Design. It was an open-label “randomized controlled trial.” Study Settings. Department of Physiotherapy, Services Hospital, Lahore, Pakistan. Participants. There were one hundred subjects with an age group between 18 and 60 years fulfilling the inclusion criteria. These subjects were divided equally into two groups; an experimental and a control group. Methods In the experimental group (n = 50), thoracic spinal manipulation was applied along with thoracic muscle strengthening exercises. In the control group (n = 50) thoracic muscle exercises alone were given. Pain was measured by visual analogue scale (VAS) and quality of life with SF-36. Measurements were taken at baseline, immediately after session, after 8th session, and later as follow-ups at 12 weeks. Repeated measure ANOVA and independent sample T-test were used for within and between-group comparisons. Results Mean age of subjects in control group was 38.56 ± 12.44 and in experimental group was 36.02 ± 11.32. Both groups demonstrated significant improvement in VAS score, and all domains of SF 36 but between-group comparison showed greater improvement in VAS of the experimental group compared to the baseline (P < 0.05), but between-group comparison of 8th session to follow-up has shown that effects of exercise persist while health-related quality of life in spinal manipulation group was significantly reduced after discontinuation of treatment. After the 8th session, spinal manipulation group showed notable results in terms of pain (mean diff 1.14 (0.62, 1.65) 95% CI and all aspects of SF 36 (P value <0.05). However, after week 12 of follow-up, no significant difference (P value >0.05) was observed among the study groups for pain and quality of life. Conclusion Spinal manipulation added to thoracic exercise was more effective than thoracic exercise alone for improving pain and quality of life at the end of 8th session of care. However, the inclusion of spinal manipulation was not found effective at the 12-week follow-up. This trial is registered with IRCT20190327043125N1.

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

P114. Intraoperative transverse process fractures and posterolateral lumbar fusion rates

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.

Sarcopenia is a muscle-wasting disease common among older adults. The condition has been associated with adverse perioperative and postoperative outcomes following spinal surgery. The combination of this muscle-wasting syndrome and spondylolisthesis and how we approached the case makes it a compelling study for surgeons attempting to treat this patient population more effectively. In this case study, we examine a 76-year-old male patient with chronic sarcopenia who needed transforaminal lumbar interbody fusion (TLIF) surgery for his grade 1 L4-5 spondylolisthesis, L4-5 degenerative disc disease, bilateral facet effusions and lumbosacral radiculopathy with active and chronic denervation. He consulted our neurosurgeon for his back pain and left lower extremity paresthesia. Magnetic resonance imaging (MRI) showed degenerative disc disease with bilateral facet effusion in multiple levels of the lumbar spine as well as broad disc bulge in L5-S1. Due to the patient’s past medical history of muscle wasting disease, a muscle biopsy of the left quadriceps was performed and revealed rare denervated fibers indicative of sarcopenia. Minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) was performed as the most optimal surgical method for this condition. The patient experienced a massive decline in his VAS score from 9/10 to 0/10 two months from surgery, reflecting the fast wound healing process and recovery. Postoperatively, the AP X-ray of the lumbar spine showed dextroscoliosis and stable L4/5 TLIF instrumentation. The surgeon provided the patient guidance regarding his nutrition and exercise to maximize the treatment. This case illustrates the employment of the minimally invasive surgery (MIS) approach to diminish complications and tissue trauma of patients with sarcopenia and spondylolisthesis who are undergoing lumbar spine surgery.

Lumbar spondylolisthesis often causes pain and disability, requiring surgical intervention. While prior studies explore the impact of body mass index (BMI) on outcomes following lumbar fusion, the effect of different surgical approaches, specifically transforaminal lumbar interbody fusion (TLIF) and lateral lumbar interbody fusion (LLIF), across BMI categories remains unclear. This study evaluates patient-reported outcomes (PROs) following TLIF and LLIF in low-grade degenerative and isthmic spondylolisthesis, focusing on BMI stratification. This study retrospectively analyzes patients with low-grade degenerative and isthmic spondylolisthesis who underwent lumbar fusion between 2010 and 2023. Patients were stratified by BMI into the following four groups: non-obese (<30), class I (30-34.9), class II (35-39.9), and class III (≥40). It assesses PROs using the Oswestry Disability Index (ODI) and visual analog scale (VAS) for pain at baseline and 12 months, comparing the achievement of minimal clinically important difference (MCID) between TLIF and LLIF. This analysis included 72 patientsshowing significant improvements in ODI (mean change: 17.0; p<0.001) and VAS (mean change: 2.3; p<0.001) scores across all BMI categories at 12 months. TLIF and LLIF achieve similar rates of MCID, with no statistically significant differences between the surgical approaches (p=0.72). Non-obese and class II patients maintain sustained improvements. Lumbar fusion using both open and minimally invasive (MIS) TLIF and LLIF leads to significant disability reduction across BMI categories, indicating that obesity does not contraindicate lumbar fusion. Surgical approach selection should focus on individual patient factors rather than BMI alone. Prospective studies with extended follow-up will further clarify the long-term impact of these approaches.

What's New in Spine Surgery.

The transforaminal lumbar interbody fusion (TLIF) procedure was developed to provide the surgeon with a fusion procedure that may reduce many of the risks and limitations associated with posterior lumbar interbody fusion, yet produce similar stability in the spine. There are few large series with long-term follow-up data regarding instrumented TLIF and placement of 1 diagonal polyetheretherketone (PEEK) cage. The authors performed a prospective study to evaluate the outcome and safety of instrumented TLIF with 1 diagonal PEEK cage for degenerative spondylolisthesis in the Han nationality in China. Between May 2001 and April 2006, 60 patients (35 men and 25 women; mean age 55.5 years, range 45-70 years) with symptomatic degenerative spondylolisthesis underwent the TLIF procedure with 1 diagonal PEEK cage and additional pedicle screw internal fixation at the authors' institution. The inclusion criteria involved degenerative spondylolisthesis (Grades I and II) in patients with chronic low-back pain with or without leg pain. One patient had a postoperative temporary motor and sensory deficit of the adjacent nerve root. Reoperation was required in 1 patient because of pedicle screw migration. One patient developed a pseudarthrosis and had increasing complaints of low-back pain 1 year postoperatively and underwent a subsequent revision surgery. Two patients had nerve root symptomatic compression resulting from cage migration and insufficient decompression after surgery, and they underwent revision. Two patients had a dural tear that required fibrin glue application during surgery. No implant fracture or subsidence occurred in any patient. Clinically, the pain index and Oswestry Disability Index (ODI) score improved significantly from before surgery to the 2-year follow-up. In the TLIF group, the pain index improved from 69 to 25 (p < 0.001). The postoperative ODI showed a significant postoperative reduction of disability during the whole period of follow-up (p < 0.001). The preoperative mean ODI score was 32.3 (16-80), and postoperative 13.1 (0-28). Disc space height and foraminal height were restored by the surgery and maintained at the latest follow-up time. In the authors' experience, instrumented TLIF with 1 diagonal PEEK cage can be a surgical option for treatment of degenerative spondylolisthesis in the Han nationality in China.

Age 65 years or older is considered a risk factor for worse outcomes after transforaminal lumbar interbody fusion (TLIF). However, few studies have differentiated this cohort from younger patients. This study compares postoperative outcomes among patients 65 years or older of age with a younger cohort after minimally invasive (MIS) TLIF. A database was reviewed for adults undergoing primary, elective, single-level MIS TLIF procedures for degenerative pathology from 2008 to 2019. Outcomes included visual analogue scale (VAS) for back and leg, Oswestry Disability Index (ODI), Short Form 12-Item physical component score (SF-12 PCS), and Patient-Reported Outcome Measurement Information System physical function. Outcomes were collected preoperatively and at 6 weeks, 12 weeks, 6 months, and 1 year postoperatively. Patients were categorized as ≥75 years, 65 to 74 years, or <65 years of age. Propensity score matching was performed, and outcome improvement and minimum clinically important difference (MCID) achievement were evaluated by group. MCID achievement was calculated using previously established values. Our cohort included 51 patients aged younger than 65 years, 47 patients aged 65 to 74 years, and 16 patients aged 75 years or older. No significant perioperative differences or complications existed between groups. The 65- to 74-year group improved in VAS back, leg, and ODI from 6 weeks to 1 year (all P < 0.001) and SF-12 PCS at 12 weeks to 1 year (all P < 0.005). VAS back, ODI, and SF-12 PCS differed between groups preoperatively (P < 0.050), and VAS back and ODI varied at 6 weeks (P < 0.01). VAS leg differed between groups at 12 weeks and SF-12 PCS at 1 year (both P < 0.050). MCID achievement was similar between groups except for VAS leg at 6 weeks (P = 0.038) and 12 weeks (P = 0.023). Patients 65 years or older of age markedly improved from baseline, similarly to younger patients. Postoperative outcome scores and MCID achievement demonstrated differences between groups at intermittent timepoints. With appropriate selection criteria, patient age may not act as a notable risk factor for successful MIS TLIF procedures.

INTRODUCTION: Transforaminal lumbar interbody fusion (TLIF) and lateral lumbar interbody fusion (LLIF) are two techniques that are widely used to treat single-level pathology at L4-5. To date, no studies have compared the two techniques in terms of their ability to address disc space pathology, such as loss of height and spondylolisthesis, and achieve spinopelvic alignment goals. METHODS: After IRB approval, this study retrospectively reviewed the records of 203 patients who underwent single-level L4-L5 TLIFs and single-level L4-L5 LLIFs between 2017 to 2022. Preoperative and postoperative scoliosis films were collected and analyzed using an automated calibrated radiographic tool to measure pre-postoperative SA and SPs. Two blinded readers measured the pre-postoperative variables. Independent Sample T-tests were used to analyze the radiographic outcomes between the two groups. RESULTS: This study evaluated the results of 203 single-level TLIFs and LLIFs (109 L4-L5 TLIFs, and 94 L4-L5 LLIFs). Among the surgeries analyzed, 90 were MIS TLIFs, 19 open TLIFs, 16 standalone LLIs, and 78 LLIFs with posterior instrumentation. Postoperative scoliosis films were taken at a median of 0.28 (± 0.4) months. The analysis focused on comparing the reciprocal changes between both procedures. Significant statistical differences was found for ΔGTilt (p = 0.036), ΔLPA (p = 0.12), ΔADH (p = 0.03), ΔPDH (p = 0.04), ΔFH (p = 0.001), and ΔS% (p = 0.01) in the LLIF group, among all the variables included in the analysis. CONCLUSIONS: L4-5 LLIF and TLIF resulted in statistically similar amounts of lordosis restoration and reciprocal change at proximal and distal lumbar levels. LLIF was found to be superior in restoration of anterior disc height, posterior disc height, and foraminal height compared to TLIF. LLIF was also superior in percentage reduction of spondylolisthesis.

ObjectiveThis study compared the radiological and clinical outcomes with transforaminal lumbar interbody fusion (TLIF) to evaluate the effect of indirect decompression through oblique lumbar interbody fusion (OLIF) as revision surgery. MethodsWe enrolled patients who underwent single-level fusion with revision surgery at the same level as the previous decompression level. We retrospectively reviewed 25 patients who underwent OLIF from 2017 to 2018 and 25 who received TLIF from 2014 to 2018. Radiologic and clinical outcomes were evaluated by cross-sectional area (CSA) of the spinal canal, thickness and area of ligamentum flavum (LF), subsidence, disc height, fusion rate, Oswestry Disability Index (ODI), and visual analogue scale (VAS). ResultsCompared with OLIF, the thickness and area of the LF after surgery were significantly less in TLIF, and the resulting CSA extension was also significantly higher. However, both groups showed improvement in ODI and VAS after surgery, and there was no difference between the groups. Complications related to the posterior approach in TLIF were 4 cases, and in OLIF, there were 2 cases that underwent additional posterior decompression surgery and 6 cases of transient paresthesia. ConclusionSince complications associated with the posterior approach can be avoided, OLIF is a safer and useful minimally invasive surgery. Therefore, appropriate indications are applied, OLIF is a good alternative to TLIF when revision surgery is considered.