Indiana Orthopaedic Hospital, also known as OrthoIndy Hospital, is a 37-bed acute care hospital that specializes in musculoskeletal therapy located in Indianapolis, Indiana. The hospital is Indiana's first specialty hospital with a focus on orthopedics. The hospital was founded in 2005 by OrthoIndy physicians to provide focused care on orthopedic procedures, physical therapy, and imaging services. It includes both inpatient and outpatient procedures, but does not provide emergency services. OrthoIndy Hospital is accredited by the American Osteopathic Association's Healthcare Facilities Accreditation Program.
BACKGROUND CONTEXT:Mechanical chronic low back pain (CLBP) associated with lumbar multifidus muscle dysfunction is a major cause of long-term disability. Available nonoperative and interventional treatments often provide limited and transient benefit. Restorative neurostimulation is intended to activate the lumbar multifidus to restore neuromuscular control and address the underlying pathophysiology of mechanical CLBP. PURPOSE:The purpose of this extension of the original randomized controlled trial was to track outcomes in a crossover group for the subsequent treatment year. Participants in the original treatment group were also followed for an additional year, allowing long-term clinical follow-up. STUDY DESIGN/SETTING:RESTORE is a postmarket, multicenter, open-label randomized controlled trial performed at 25 clinical sites in the United States. PATIENT SAMPLE:A total of 203 participants were randomized 1:1 to restorative neurostimulation or optimal medical management. At the completion of the randomized phase, 80/96 (83%) eligible control participants elected to cross over to restorative neurostimulation treatment. These participants and the original treatment group were followed for an additional year. OUTCOME MEASURES:Oswestry Disability Index (ODI), back pain (Numerical Rating Scale [NRS]), and health-related quality of life (EuroQol 5-Dimension 5-Level [EQ-5D-5L]) were assessed at 18 and 24 months postrandomization. Outcomes included responder rates based on minimal clinically important change thresholds, pain remission, composite responder definitions, work ability, subject global impression of change, opioid use, and number needed to treat. METHODS:This prespecified delayed-start crossover analysis included a nonrandomized comparison of outcomes between early and delayed-start treatment groups, with within-group analyses serving as the primary basis for inference regarding crossover efficacy. Longitudinal outcomes for the treatment group were analyzed using mixed models for repeated measures. Crossover group outcomes were analyzed using completer analyses. RESULTS:The treatment group improvements were sustained through 24 months, with mean changes from baseline of -24.6±17.1 in ODI, -4.2±2.4 in NRS, and +0.189±0.163 in EQ-5D-5L (all p<.001). After crossover, participants demonstrated significant improvements after 1 year of active therapy, with mean changes from baseline of -21.1±14.8 in ODI, -3.8±2.2 in NRS, and +0.191±0.144 in EQ-5D-5L (all p<.001), comparable in magnitude to those observed in the treatment group at the same timepoint. At 12 months, responder rates in the treatment group were 70% for ODI ≥15 point improvement, 53% for ≥50% NRS reduction, 52% for NRS remission, and 72% for the composite endpoint, compared with 17%, 6%, 6%, and 12% in the control group, respectively; after crossover, corresponding responder rates at 12 months of active therapy were 64%, 61%, 60%, and 73%, consistent in magnitude with those observed in the treatment group at the equivalent timepoint of therapy. Corresponding numbers needed to treat ranged from 1.7 to 2.2 and remained similarly low when the crossover outcomes were compared with control. CONCLUSIONS:These findings reinforce the role of restorative neurostimulation as an effective therapeutic option for patients with multifidus dysfunction-related CLBP who have exhausted conservative care and suggest that earlier intervention may reduce prolonged disability and loss of quality of life.
Many interventional strategies are commonly used to treat chronic low back pain (CLBP), though few are specifically intended to target the distinct underlying pathomechanisms causing low back pain. Restorative neurostimulation has been suggested as a specific treatment for mechanical CLBP resulting from multifidus dysfunction. In this randomized controlled trial, we report outcomes from a cohort of patients with CLBP associated with multifidus dysfunction treated with restorative neurostimulation compared to those randomized to a control group receiving optimal medical management (OMM) over 1 year. RESTORE is a multicenter, open-label randomized controlled trial. Candidates were assessed for CLBP associated with multifidus dysfunction, with no indication for or history of lumbar spine surgery. Participants were randomized to either restorative neurostimulation with the ReActiv8 system or OMM. The primary endpoint was a comparison of the mean change in the Oswestry Disability Index (ODI) between the treatment and control arms at 1 year, and secondary endpoints included pain (numeric rating scale [NRS]) and health-related quality of life (EuroQol Five-Dimension [EQ-5D-5L]). A total of 203 patients, average age 47 years, and with an average 11-year history of low back pain, were included in the analysis. The primary endpoint was a statistically significant demonstration of a clinically relevant mean improvement in the Oswestry Disability Index (ODI) between restorative neurostimulation and OMM arms: ODI (−19.7 ± 1.4 vs. −2.9 ± 1.4; p < 0.001). Additionally, improvements in both the numeric rating scale (NRS) (−3.6 ± 0.2 vs. −0.6 ± 0.2; p < 0.001) and EuroQol Five-Dimension (EQ-5D-5L) (0.155 ± 0.012 vs. 0.008 ± 0.012; p < 0.001) were statistically and clinically significant in the restorative neurostimulation arm compared to the OMM arm. The RESTORE trial demonstrates that restorative neurostimulation is a safe, reversible, clinically effective, and highly durable option for patients suffering with nonoperative CLBP associated with multifidus dysfunction. This demonstration of treatment superiority over OMM through 1 year is a significant milestone in addressing a major health burden and unmet clinical need. ClinicalTrials.gov Identifier: NCT04803214. Chronic low back pain can occur as a consequence of dysfunction in the key stabilizing muscles of the spine, the multifidi. This type of low back pain is difficult to treat, with many interventions resulting in limited improvement or short-term relief for a significant proportion of patients. Despite this limitation, these approaches still represent the best available care in most practices. Restorative neurostimulation is a technique that stimulates dysfunctional multifidi, overriding muscle inhibition to improve spinal function, reduce disability, and alleviate pain. The hypothesis was that this treatment is appropriate for a specific subset of patients who have failed to respond to best available conservative and interventional care. The goal of this study was to compare the effect of restorative neurostimulation to standard-of-care interventions (optimal medical management) for patients with chronic mechanical low back pain. Patients with an average 11-year history of chronic low back pain and diagnosed with multifidus dysfunction were randomly assigned to either ongoing optimal medical management or restorative neurostimulation. At 1 year, disability, pain, and healthcare-related quality of life were assessed. Patients treated with restorative neurostimulation demonstrated significant improvements in their clinical outcomes compared to those receiving optimal medical management alone. Device-related adverse events were rare, reinforcing the safety profile of this technique. This study demonstrated that without restorative neurostimulation, patients with chronic low back pain and multifidus dysfunction have very few effective options and obtained little clinical benefit from ongoing optimal medical management. Restorative neurostimulation is an important advancement for this difficult-to-treat population.
BACKGROUND:Individually, robotic guidance and 3-dimensional navigation assistance have been shown to improve surgical outcomes and accuracy in spine surgery. The pairing of these technologies may further improve outcomes; however, data are needed to support this theory. In the Prospective Robotic-Guided Registry of Spine Surgery (PRoGRSS), outcomes were tracked for cases using a bone-mounted integrated robotic-assisted navigation system. This interim analysis reports on 90-day complications and revisions. METHODS:Adults undergoing navigated robotic thoracolumbar surgery from 2020 to 2022 were prospectively enrolled by 6 surgeons at 4 distinct centers. Medical, surgical, and robot-related complications and revision surgeries were collected postoperatively for up to 90 days and analyzed. RESULTS:Of 411 surgeries, 3469 screws were implanted. The mean number of levels fused was 4.4 ± 3.7. Intraoperative adverse events occurred in 4.1% of cases, and 0.5% were robot related. The frequency of patients with at least 1 postoperative surgical complication was 6.6%, none being robot related. The frequency of patients with at least 1 postoperative medical complication was 18.2%. The revision surgery rate at 90 days was 1.5%, none of which were robot related. CONCLUSION:This first-of-its-kind study of an integrated navigation and robotic spine platform demonstrates low complication and revision surgery rates for thoracolumbar fusion. This interim analysis of PRoGRSS showed 4.1% intraoperative complications, 6.6% postoperative surgical complications, and 1.5% revision surgeries. With advancements in technology and increased surgical expertise, navigated robotics continues to demonstrate consistently low rates of 90-day complications and revision surgeries, supporting its reliability. CLINICAL RELEVANCE:The interim analysis of PRoGRSS suggests that the integration of robotic guidance with 3-dimensional navigation is reproducibly effective in the surgical setting. LEVEL OF EVIDENCE: 2:
Prospective, multicenter, single-blind, randomized, and 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 (22–80 y) 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 with 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 one 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 group 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. Level I.
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.
