15 research outputs found
The Use of Recombinant Human Bone Morphogenetic Protein 2 (rhBMP-2) to Promote Spinal Fusion in a Nonhuman Primate Anterior Interbody Fusion Model
Study Design. A study on the efficacy of recombinant human bone morphogenetic protein 2 (rhBMP-2) in a nonhuman primate anterior interbody fusion model.
Objectives. To investigate the efficacy of rhBMP-2 with an absorbable collagen sponge carrier to promote spinal fusion in a nonhuman primate anterior interbody fusion model.
Summary of Background Data. RhBMP-2 is an osteoinductive growth factor capable of inducing new bone formation in vivo. Although dosage studies using rhBMP-2 have been performed on species of lower phylogenetic level, they cannot be extrapolated to the primate. Dosage studies on nonhuman primates are essential before proceeding with human primate application.
Methods. Six female adult Macaca mulatta (rhesus macaque) monkeys underwent an anterior L7-S1 interbody lumbar fusion. All six sites were assigned randomly to one of two fusion methods: 1) autogenous bone graft within a single freeze-dried smooth cortical dowel allograft cylinder (control) or 2) rhBMP-2-soaked absorbable collagen sponges within a single freeze-dried smooth cortical dowel allograft cylinder also soaked in rhBMP-2. The animals underwent a baseline computed tomography scan followed by 3- and 6-month postoperation scans. Anteroposterior and lateral radiographs of the lumbosacral spine were performed monthly. After the monkeys were killed, the lumbar spine fusionsites were evaluated. Histologic evaluation of all fusion sites was performed.
Results. The three monkeys receiving rhBMP-2-soaked collagen sponges with a freeze-dried allograft demonstrated radiographic signs of fusion as early as 8 weeks. The control animals were slower to reveal new bone formation. The computed tomography scans revealed extensive fusion of the L7-S1 lumbar vertebrae in the group with rhBMP-2. A pseudarthrosis was present in two of the control animals.
Conclusions. This study was able to document the efficacy of rhBMP-2 with an absorbable collagen sponge carrier and a cortical dowel allograft to promote anterior interbody fusion in a nonhuman primate model at a dose of 0.4 mg per implant site (1.5 mg/mL concentration). The rate of new bone formation and fusion with the use of rhBMP-2 and cortical dowel allograft appears to be far superior to that of autogenous cancellous iliac crest graft with cortical dowel allograft
Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study
PurposeTo evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP.MethodsA total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25–69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months.ResultsAt 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months.ConclusionPatients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain.Graphical abstract These slides can be retrieved under Electronic Supplementary Material. Open image in new windo
Answer to the letter to the editor of Y. Li et al. concerning “Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study” by Fischgrund JS, et al. [Eur Spine J; (2018) 27(5): 1146–1156]
Association Between Opioid Use and Patient-Reported Outcomes in a Randomized Trial Evaluating Basivertebral Nerve Ablation for the Relief of Chronic Low Back Pain
Single- Versus Multilevel Fusion for Single-Level Degenerative Spondylolisthesis and Multilevel Lumbar Stenosis
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207. FDA trial of decompression and dynamic sagittal tether for degenerative spondylolisthesis: 24 months clinical and radiographic follow-up
Degenerative spondylolisthesis (DS) with lumbar spinal stenosis (LSS) is commonly treated with decompression and fusion. The LimiFlex Dynamic Sagittal Tether (DST) is an investigational stabilization device for patients with DS and LSS.
The purpose of this study is to assess the clinical and radiographic outcomes of decompression and DST compared to transforaminal lumbar interbody fusion (TLIF) for patients with DS and LSS.
Multicenter prospective concurrently controlled study.
Patients undergoing treatment (decompression and DST or TLIF stabilization) of Grade I Meyerding lumbar degenerative spondylolisthesis.
Patients undergoing treatment (decompression and DST or TLIF stabilization) of Grade I Meyerding lumbar degenerative spondylolisthesis.
Patients with single-level Grade I DS with LSS were enrolled in the FDA-IDE study (NCT03115983) comparing decompression with DST and decompression with TLIF. Clinical and radiographic outcomes were assessed at baseline and 6-week, 3, 6, 12 and 24-month follow-up. All propensity score (PS) selected patients who had 24-month follow-up were included in this interim analysis. Summary statistics are reported, as well as paired t-tests to assess within-group changes.
At 24 months, 228 PS-selected patients (129DST/99TLIF) had clinical follow-up and 197 (117DST/80TLIF) had radiographic follow-up. Mean characteristics of DST and TLIF groupswere: age 65.5/64.1 yrs; BMI 28.1/30.5; CCI 0.43/0.41, respectively. Mean perioperative outcomes for DST/TLIF were: procedure time 112/189 min; EBL 53/232 mL; LOS 0.7/3.2 nights. A significant reduction at 24 months for mean VAS-leg/hip (79.5 to 22.9), VAS-back (66.8 to 19.0) and ODI (52.8 to 13.2) was reported for DST patients (all p < 0.01) with 91% achieving 15-point ODI improvement. TLIF patients demonstrated similar improvements for VAS-leg (80.6 to 24.4), VAS-back (68.1 to 26.1) and ODI (52.3 to 20.9) (all p < 0.01), with 80% achieving 15-point ODI improvement. While there was no difference at baseline, the DST group had lower ODI at all postoperative timepoints. Within the 24 months, 9% of each group had additional surgery at the index or adjacent level. At 24 months, the DST group had mean reductions of 1.7° ROM and 0.4mm translation in flexion/extension images compared to 3.8° and 1.0mm reductions in the TLIF group. Considering the index and adjacent segments together (IAS), the index segment accounted for 30% of IAS ROM at baseline and 27% at 24 months in the DST group compared to 29% at baseline and 13% at 24 months in the TLIF group.
These results suggest that decompression with DST stabilization for spondylolisthesis can achieve significant clinical improvement as is expected with fusion, without an increase in reoperations during the 24 months postoperative period. Similarly, statistically significant improvements in patient-reported outcomes were demonstrated in each group, with lower disability scores in the DTB group at all postoperative timepoints. Imaging demonstrated no increased instability in the DST group with maintained distribution of motion between the index and adjacent segments. While these groups were PS-selected, further analyses should include quantitative comparison between groups with PS-adjusted differences per the predefined composite clinical success criteria for a definitive comparison of outcomes.
LimiFlex Dynamic Sagittal Tether (Investigational/Not Approved)
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P285. Radiographic predictors of instability vs composite clinical success of spondyloplasty of TLIF for degenerative spondylolisthesis. Analysis of results from a prospective FDA IDE trial
Blumenthal et al (2013) found that segmental facet joint angle (FJA) >50°, disc height (DH) >6.5mm and segmental translation (ST) >1.25mm were associated with higher rates of reoperation in patients who had decompression only, without fusion, for symptomatic degenerative spondylolisthesis (DS). An ongoing FDA IDE study (NCT03115983) is comparing spondyloplasty (decompression and dynamic sagittal tether (DST) stabilization vs decompression and transforaminal lumbar interbody fusion (TLIF) for symptomatic DS. Radiographic measures including those identified by Blumenthal may identify signals among subgroups with clinical success or failure.
The purpose of this analysis is to assess composite clinical success (CCS) among spondyloplasty and TLIF subjects having a PDI.
Post-hoc analysis of data from a multi-center, prospective IDE study of spondyloplasty vs TLIF for symptomatic DS (NCT03115983).
A total of 299 subjects enrolled in the IDE trial of spondyloplasty (N=140) vs TLIF (N=159). Full study inclusion criteria provided at clinicaltrials.gov (NCT03115983).
Primary outcome measure CCS was defined as patients meeting all of the following through 24-months: successful index implantation; 15-point improvement on the Oswestry Disability Index (ODI); no device integrity failure defined as device breakage, separation, dislocation or disassembly; no subsequent surgical intervention (SSI) at the index or adjacent segments; and no decrease in neurologic status unless attributable to a concurrent medical condition or other unrelated cause. PDI were defined as ST>1.25mm, FJA>50° or DH>6.5mm as measured on preoperative radiographs.
CCS rates were calculated for each subgroup of patients having or not having each individual PDI, all PDI, any PDI or no PDI in each of the two treatment arms. Influence of each PDI was assessed using student's t-test to compare subjects with and without the PDI.
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There was no identifiable relationship between any of the preoperative radiographic parameters and clinical success in either the spondyloplasty or TLIF groups. Notably, failures in the spondyloplasty group were not associated with higher preoperative mobility, disc height, anterolisthesis or FJ angle, as has been seen in decompression alone.
LimiFlex Dynamic Sagittal Tether (Investigational/Not Approved), Standard of Care TLIF instrumentation and graft materials (Approved for this indication