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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). [ABSTRACT FROM AUTHOR]

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. Assess return to work (RTW) and activities of daily living (ADL) receiving either decompression and DST stabilization (D+DST) or decompression and transforaminal lumbar interbody fusion (D+TLIF). Interim analysis from a multicenter, concurrently controlled study. Patients undergoing treatment (D+DST or D+TLIF) of Grade I Meyerding lumbar DS. Propensity score (PS) selected patients with 12-month follow-up were included. Time to RTW and activities of daily living, as well as Oswestry disability index (ODI). PS-selected IDE study subjects with 12 months of follow-up were included in this analysis. Study records queried for work status preoperatively and at 12 months, as well as time to RTW and ADL, and change in disability (Oswestry Disability Index; ODI) at 12 months vs preop. Outcomes were compared using student's t-tests. PS-selected subjects totaled 267 (136 D+DST, 131 D+TLIF). Preoperatively, 49% of D+DST and 43% of D+TLIF subjects were working (p=0.14) and 7% D+DST and 11% D+TLIF were not working due to spinal condition (NWSC) (p=0.13). At 12 months postop, 44% of D+DST and 34% of D+TLIF subjects were working (p=0.05) and 2% D+DST and 10% D+TLIF were NWSC (p<0.01). Proportion of D+DST NWSC was significantly lower 12 months postop compared to preop (p=0.02). Mean±SD RTW time for D+DST/D+TLIF subjects was 5.4±6.6/11.8±9.6 weeks (p<0.01) and return to ADL time was 5.5±6.5/10.0±9.5 weeks (p<0.01). Mean±SD reduction in disability at 12 months from baseline was 38.1±18.4 for the D+DST group and 31.8±20.7 for the D+TLIF group (p<0.01) with effect sizes of -2.1 and -1.5, respectively. The primary objective of surgery for symptomatic DS is resolution of symptoms so patients can return to their normal ADL and work. Both D+DST and D+TLIF treated patients demonstrated a significant reduction in disability at 12-month follow-up. Significantly faster RTW and ADL were observed for D+DST compared to D+TLIF patients, by an average of more than 5 weeks. The proportion of D+DST patients NWSC was significantly less than at 12 months. Results indicate a significant advantage of earlier recovery for the D+DST patients allowing earlier RTW and earlier increase in ADLs compared to D+TLIF, with similar or greater improvements in disability after one year for patients treated with decompression and stabilization for symptomatic DS. Longer-term follow-up assessment with propensity score-adjusted outcomes will demonstrate whether this advantage and long-term outcomes are durable and generalizable. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

i-FACTOR is a composite bone substitute material consisting of a P-15 synthetic collagen fragment adsorbed onto an organic bone mineral and suspended in an inert biocompatible hydrogel carrier. Previous analyses of the US FDA IDE study demonstrated the benefits of i-FACTOR compared to local autograft bone in single-level ACDF at 12- and 24-months postoperative. We report 6-year clinical and radiological outcomes of post-approval study. Subjects from a completed, prospective, randomized, controlled, multicenter clinical trial that was conducted at 22 North American sites were enrolled in a post-approval study and we report 6-year outcomes. Of 319 subjects that participated in the IDE study, 220 were enrolled into post-approval 6 years follow-up autograft (n = 114) or i-FACTOR (n = 105) in a cortical ring allograft. Radiological, clinical, and patient-reported outcomes. Subjects completed prospective, randomized, controlled, multicenter clinical trial that was conducted at 22 North American sites were enrolled into post-approval study 6 years follow-up. Fusion rates at 72 months were 99.0% in i-FACTOR subjects and 98.2% in autograft subjects, with a difference of 0.8% (95% C.I., (95% CI -2.3%, 4.0%). Mean improvement in NDI in i-FACTOR subjects was 28.56 (95% CI 24.79, 32.33) compared to 29.17 (95% CI 25.46, 32.88) in autograft subjects, with a difference of -0.61 (2.793) (95% CI -6.10, 4.88). Neurologic success rate at 72 months was 95.89% in i-FACTOR subjects and 93.33% in autograft subjects, with a difference of 2.6% (95% CI, -4.70%, 9.81%). Overall success rate was 68% in i-Factor and 62% in autograft subjects. Safety outcomes were similar between the 2 treatment groups. Secondary surgery at any cervical level occurred in 20 (18.9%) i-FACTOR subjects and 23 (20.2%) autograft subjects (p=0.866). Pain and SF-36 outcomes were similar between the groups at all study visits. There were no adverse reactions associated with i-FACTOR. At 6 years, i-FACTOR in ACDF resulted in similar outcomes compared to local autograft. Safety outcomes are acceptable and clinical and functional outcomes for i-FACTOR in the previous studies are confirmed. I-Factor (Approved for this indication) [ABSTRACT FROM AUTHOR]

Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. PEEK is used increasingly for spinal implants due to its mechanical properties and lack of artifact on imaging. A cervical TDR was designed with commercially pure titanium-coated PEEK endplates and a biconvex zirconia toughened alumina ceramic core. The purpose of this study was to compare this PEEK-on-ceramic TDR to anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration. This was a prospective, nonrandomized, multicenter Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial comparing the investigational group to a propensity-matched historic control group. Patients received the PEEK-on-ceramic Simplify® Cervical Artificial Disc (n=150 patients from 16 sites). The historic control group included 117 propensity-matched ACDF patients from an earlier cervical TDR IDE trial employing the same inclusion/exclusion criteria. All patients were treated for single-level symptomatic cervical disc degeneration. The primary outcome was a composite 5-point success classification at 24-month follow-up requiring: >15 point (of 100) improvement in Neck Disability Index (NDI) score; 2) maintenance/improvement in neurologic status; 3) no device failure; 4) no reoperation/revision/removal and/or supplemental fixation at the index level, and 5) no major adverse events. Outcome measures included NDI, visual analog scale (VAS) assessing neck and arm pain, neurological status, adverse events and subsequent surgery. Radiographic assessment included flexion/extension range of motion. Facet joints were assessed at 24 months comparing pre- to postoperative MRI images using a published 4-point scale. Evaluations were performed preoperatively and postoperatively within 2 and 6 weeks, and 3, 6, 12 and 24 months. The control was propensity match with ACDF patients from an earlier TDR vs ACDF trial, which used the same inclusion criteria and primary outcome assessments. The overall composite success rate was significantly greater in the TDR group vs ACDF (93.0% vs 73.6%; p<0.001). Mean NDI, neck pain and arm pain scores improved significantly in both groups at all follow-up points. Mean NDI scores in the TDR group were significantly lower than ACDF scores at all follow-up points all p<0.01). Secondary surgical intervention was undertaken in 4 (2.7%) patients at the index level in the TDR group and 6 (5.1%) in the ACDF group. There were no significant differences in the rates of serious adverse events when comparing the two groups. The mean segmental range of motion of the treated level in the TDR group was 7.3° prior to surgery. This increased to 8.6° at 3-month follow-up and continued to increase to 9.6° at 24 months (p<0.001). Facet joint assessment by MRI at 24-month follow-up in the TDR group showed little change from preoperative. The results of this study found that the Simplify® Cervical Artificial Disc produced outcomes similar or superior on some measures, including superiority in the composite success classification, compared with ACDF, for the treatment of single-level symptomatic cervical disc degeneration. ROM at the treated level increased from the preoperative value and was maintained throughout follow-up. Safety of the PEEK-on-ceramic disc was established with no device failures in the series. These results support that the device is a viable alternative to ACDF. Simplify Cervical Disc Replacement (Approved for this indication) [ABSTRACT FROM AUTHOR]

Interspinous process distraction (IPD) devices aim to alleviate back and leg pain by limiting extension and unloading the 3-joint complex at the affected lumbar level. IPDs may offer a treatment option for painful degenerative disc disease (DDD) that is not yet indicated for fusion or disc replacement. To compare the safety and effectiveness of IPD and nonoperative treatment after 2 years for the treatment of moderate lumbar DDD. A prospective, randomized, controlled FDA IDE clinical trial at 23 US centers (ClinicalTrials.gov: NCT00456378). A total of 278 patients with moderate low back pain for less than 1 year and radiographic evidence of single-level DDD between L2 and L5 who failed at least 6 weeks but less than 6 months of conservative management were randomized and treated with investigational IPD (n=181) or control nonoperative treatment (n=97). The primary endpoint was Overall Success, a composite variable that included: 1) Oswestry Disability Index (ODI) score improvement of ≥ 15 points; and 2) no serious adverse event (AE) caused by the implant or by both the implant and surgical procedure (IPD) or caused by the nonoperative treatment (control); and 3) no secondary surgery (IPD) or treatment surgery (control) at the involved level. Additional safety and effectiveness endpoints included back and leg pain numerical (0-20) rating scales, SF-36 PCS/MCS, AEs and secondary surgeries. Investigational treatment consisted of the IPD implantation (without decompression) and nonoperative treatments, as necessary. Control treatment consisted of information/ education on low back pain, medication, physical therapy, and epidural and/or facet joint steroidal injections. Clinical and radiographic assessments were performed preoperatively, intra-operatively, and postoperatively up to 2 years. Statistical analyses used Bayesian methods with non-informative priors. Last observation was carried forward (LOCF) for patients lost to follow-up including patients receiving surgery (control crossovers) or additional surgery (IPD investigational) at the involved level. Baseline demographic characteristics and outcomes scores were not statistically different between the two groups, except back pain (16.8 for investigational vs 16.1 for control, p=0.033). The IPD rate of Overall Success at 24-months was statistically superior to control (observed rate of 63.0% vs 13.4%, respectively; posterior probability of superiority (pps) > 99.9%). The improvement in outcomes for IPD was statistically superior to control (pps > 99.9%) for: ODI (26.4 vs 1.1), back pain (8.4 vs 1.2), leg pain (4.9 vs -1.1, PCS (12.6 vs.1.4), and MCS (4.4 vs -0.8). Spinous process bony erosion increased slowly to 33.7% (61/181) of patients but was not related to clinical outcomes. Treatment-related serious AEs in the control group were associated with increasing low back pain. Fifteen (8.3%) IPD and 34 (35.1%) control patients experienced a treatment-related serious AE. Twenty (11.0%) IPD patients had secondary surgery and 10 (10.3%) control patients had treatment surgery at the index level. After 6 months of nonoperative treatment, control patients had the option to crossover to IPD: 57 (58.8%) control patients had crossed over by 24 months. These analyses support the superiority of this IPD over conservative care for moderate back pain in appropriately selected patients. DIAM™ Spinal Stabilization System (Investigational/Not approved) [ABSTRACT FROM AUTHOR]