Prospective randomized controlled trial. This trial was designed to understand safety and effectiveness outcomes in subjects with three-level cervical degenerative disc disease treated with anterior cervical discectomy and fusion (ACDF) alone or supplemented with a posterior cervical fusion (PCF) performed using an investigational posterior cervical stabilization system (PCSS). ACDF remains the most common surgical treatment for cervical disc disease. Long-segment (3+ disc levels) procedures are associated with increased risk of complications including symptomatic nonunion. Supplementing ACDF with PCF to form a circumferential cervical fusion (CCF) improves biomechanical stability but increases the surgical burden for the patient. This multicenter study compared outcomes in participants with three-level symptomatic cervical disc degeneration treated with either ACDF or CCF. The CCF procedure incorporated PCF with PCSS. The primary endpoint was 12-month fusion success, defined by bridging bone across the interbody and range of motion <2° across all treated disc levels. The 24-month secondary endpoint was a composite of fusion success, neck disability index (NDI) improvement, neurological status success, and freedom from surgical revision. This protocol-defined interim analysis included 202 participants with 12-month outcomes and 116 participants with 24-month outcomes. Twelve-month fusion success was higher for CCF (61/100, 61%) compared with ACDF (17/102, 17%) (P<0.001). The 24-month secondary endpoint was also improved with CCF compared with ACDF [51% (30/59) vs. 23% (13/57); P=0.002]. Revision rates were lower for CCF (1/59, 2%) compared with ACDF (13/57, 23%) (P<0.001), with 11 of 13 ACDF revisions addressing symptomatic nonunion. Adding supplemental PCF with PCSS did not increase the rates of adverse events (ACDF=65%, CCF=46%, P=0.005). This study represents the first randomized controlled trial assessing treatment of three-level cervical disc disease. Long-segment ACDF demonstrated low fusion rates and high rates of revision. Adding supplemental PCF with PCSS improved fusion without increasing the risk of surgical complications.
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.
BACKGROUND:Spinal cord stimulation (SCS) is commonly utilized for managing chronic intractable pain associated with spinal conditions, complex regional pain syndrome (CRPS), neuropathic pain, and peripheral neuropathy. Although rare, complications such as dermatologic reactions and lead-related allergies have been reported. However, penile pain with allodynia has not been previously documented. We present a unique case of penile pain with allodynia following successful SCS implantation and initial pain relief. CASE REPORT:A 53-year-old man underwent implantation of a Boston Scientific spinal cord stimulator with leads positioned at the T8 level, covering the T9-T10 interspace. This followed a successful trial that resulted in 70% pain relief and functional improvement for chronic low back and lower extremity pain due to post-laminectomy syndrome. Following the permanent implant, the patient experienced approximately 40% relief over two months. Subsequently, the stimulator stopped providing effective relief, and he reported ongoing low back pain along with the new onset of penile pain. Despite multiple reprogramming attempts, he developed significant anxiety over his symptoms. Dermatological and urological evaluations were unremarkable. Pharmacologic interventions, including Gabapentin, followed by Pregabalin, opioids, and THC, were ineffective. The penile pain persisted regardless of whether the stimulator was active. After comprehensive discussions and shared decision-making, the stimulator was explanted. Post-surgery, the patient recovered well, and his penile discomfort resolved immediately. CONCLUSION:SCS can potentially lead to rare complications such as penile discomfort. In such cases, explantation of the device may be the only effective resolution.
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.
BACKGROUND:Spinal cord stimulation (SCS) is commonly used in the cervical spine to manage chronic intractable pain. However, complications can include lead displacement, lead migration, and lead fracture. CASE REPORT 1: The first case is of a 67-year-old woman who underwent spinal cord stimulator implantation in 2009 for the treatment of complex regional pain syndrome (CRPS). The device used was a Medtronic Restore system with an Octad 1×8 single lead array, and the battery was replaced in 2021. In December 2023, the patient began experiencing new-onset symptoms including dizziness, headaches, and balance disturbances. Due to these emerging neurological symptoms and the necessity for magnetic resonance imaging (MRI), the SCS system was explanted. CASE REPORT 2: The second case is of a 78-year-old woman who underwent spinal cord stimulator implantation in 2011 for the treatment of CRPS. The system used was a Medtronic RestoreUltra with an Octad 1×8 dual lead array. In 2020, the battery was replaced with a Medtronic Intellis pulse generator due to end-of-life. In 2021, following a motor vehicle accident, the patient began experiencing electric shock-like sensations whenever the spinal cord stimulator was activated. A system interrogation was performed in 2022, which failed to resolve the issue. Due to the persistent uncomfortable sensations and lack of therapeutic benefit, she requested removal of the system, which was explanted in May 2025. Post-explantation imaging revealed that the distal electrode of one lead remained in the cervical spine. CONCLUSION:These two case reports highlight unusual presentations of cervical spinal cord stimulator lead fracture with or without loss of stimulation effectiveness. However, in the first case, despite the continued functionality of the device, the patient developed unexplained neurological symptoms and required MRI imaging. These symptoms improved following device removal, even though a portion of the electrode remained in place. In the second case, stimulation produced uncomfortable electrical sensation requiring electrical stimulation. During the surgical procedure, post-explantation imaging revealed that the top electrode remained in the cervical spine, which in both cases was not identified until after explantation.
