Loveland

Screening and Patient Selection Subjects will be selected from the pool patients of routine care who meet all the inclusion criteria for this study and none of the exclusion criteria, as described in Section 9.3. Candidates will be given a patient information sheet (or Informed Consent) either in clinic or sent via post. Each approached candidate will be logged, assigned a screening number, and evaluated by the site research team. Subjects who sign the Informed Consent for participation and meet the Inclusion and Exclusion criteria will be enrolled and listed with an enrollment number. Recruitment will continue competitively until at least 84 subjects have evaluable data for evaluation of the primary endpoint. Average pain levels will be captured at screening/baseline. Diagnostic Injection A diagnostic injection of the IPS under ultrasound, fluoroscopy or landmark guided in the clinic will be performed administering no more than 2cc of anesthetic. No steroids are allowed for the diagnostic injection. Only those subjects with significant temporary pain relief (\> 75%) compared to the average pain level captured at baseline, and after at least 2 hours of the injection, will be allowed to continue with the study. Trial Implant All subjects will be brought to the procedure room or operating room (OR) for the trial implant procedure under local anesthetic. An introducer will be placed under ultrasound or fluoroscopic guidance at the target nerve and the electrodes percutaneously advanced towards the IPS. After insertion of the receiver and then confirmation of stimulation, the trial stimulator will be secured to the skin. The stimulator tail will be outside the body and attached to the skin. All subjects will undergo an active 7-day provisional test period. Only those subjects reporting \> 50% pain relief at the end of the 7-day provisional test period as compared to the average pain level captured at baseline will be allowed to continue with the study. The trial leads will be removed at the end of 7 days. Permanent Implant All subjects responding to therapy with \> 50% pain relief at 7 days will, at a later date, be brought to the operating room (OR) and given a sedative and local anesthetic for implantation of a permanent electrode. An introducer will be placed under ultrasound or fluoroscopic guidance onto the target nerve and the electrode array advanced towards the nerve. The receiver will be mated with the electrode array, and, after confirmation of stimulation, the permanent stimulator will be tunneled and secured. The device will remain inactive for 10 days to allow for satisfactory healing. If no localized infection or other complication, subjects can be brought back to the office for randomization. Randomization/Blinding Subjects will be randomized to either active sub-threshold (high frequency) stimulation or no stimulation (sham) by Curonix's Clinical Support. All subjects, the investigator and the research team will be blinded to the group assignment for up to 30 days from the moment of randomization. Office Study Visits After randomization follow-up visits will be conducted at 1 week, 1 month, 3 months, and 6 months. Initial and follow-up evaluations will consist of physical exams, pain scale (m-MPS), Knee Injury \& Osteoarthritis Outcome Score Junior (KOOS Jr), range of motion (flexion and extension measured by goniometer, work status and medication intake evaluation. At 1-month post-randomization, all subjects will be unblinded. Active devices can be adjusted for optimal pain relief. Sham devices will be reprogrammed to receive active treatment. Available stimulation programs include tonic (on table testing), 500 Hz, 1000 Hz 1499 Hz frequency stimulation, all of which may be utilized on the same subject. Remote Study Visits Follow up phone calls at 12 months, 18 months, and 24 months post-implantation will be performed to confirm durability of pain relief with the m-MPS and the global perceived effects scale (GPES). Any adverse events will be assessed and captured as part of the study.

Researchers are conducting the REALITY study to collect both short- and long-term safety and effectiveness data on people implanted with Abbott's neurostimulation systems for chronic pain. This prospective, open-label, multi-center study includes a broad range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. Enrollment is planned to be completed within 7 years, with an overall study duration of 13 years including follow-up and close out. Participants will receive market-approved Abbott neurostimulation devices, specifically spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRG) systems. Individuals scheduled to receive implantation within 60 days of the baseline visit can join the study. The study does not randomize or compare treatments but monitors the implanted devices over time to gather safety and performance information. During the study, participants will be followed for up to 5 years after implantation with regular assessments to track device- and procedure-related adverse events, deaths, and device deficiencies. These safety outcomes will be measured at multiple time points including baseline, the permanent implant procedure, and every six months up to five years. The study also involves collecting data on patient experience and device performance throughout this period.

Researchers are evaluating the effectiveness and safety of the Aurora Spine ZIP™ MIS Interspinous Fusion System combined with bone graft material for treating adults with chronic low back pain caused by degenerative disc disease accompanied by neurogenic claudication. This condition involves pain due to disc degeneration in the lumbar spine, often leading to symptoms like lower extremity discomfort and difficulty walking. The study focuses on patients who have experienced symptoms despite at least three months of non-surgical treatment and have mild to moderate spinal stenosis confirmed by MRI. The treatment being studied is a minimally invasive interspinous fusion device called the Aurora Spine ZIP™ MIS Interspinous Fusion System. This device is a bilateral locking plate system that attaches to the spinous processes of the spine between T12 and S1 vertebrae through an interlaminar approach. It includes a central chamber for bone graft material to support fusion. Participants will undergo single-level spinal fusion using this device to address their lumbar degenerative disease and associated symptoms. During the study, participants will be monitored for improvements in pain and function over time, with key outcome measures including a reduction of more than 20mm in back pain while standing, assessed at 3 and 12 months after treatment. Researchers will collect data through pain scores, physical function questionnaires, and radiographic studies to evaluate the device's safety and effectiveness. The total duration of participation includes follow-up assessments at specified intervals up to one year post-procedure.