Rockwall

This research aims to find out if a treatment called cryoneurolysis can reduce pain after reverse total shoulder replacement surgery RTSA. Cryoneurolysis uses cold to temporarily block a nerve in the shoulder. The study compares those who receive this treatment before surgery to those who do not, to see if it lowers pain and reduces the need for opioid pain medications after RTSA. The trial is a randomized controlled pilot study involving two groups one receiving cryoneurolysis of the suprascapular nerve before RTSA and one not receiving this treatment. Cryoneurolysis is applied pre-operatively to study its effect on pain control and opioid use. The study will measure outcomes over a 90-day period following surgery. Participants will be monitored through various assessments including opioid usage measured by morphine milligram equivalents, pain scores using the Pain Assessment Documentation Tool, shoulder range of motion evaluations, and patient-reported outcomes via the American Shoulder and Elbow Surgeons shoulder score. The study involves pre-operative treatment, surgery, and follow-up assessments over three months to evaluate safety and effectiveness.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are conducting a global, prospective, multi-center observational study to gather real-world data on the long-term effectiveness, economic value, and technical performance of Boston Scientifics commercially approved neurostimulation systems for pain management. The study focuses on patients using these neurostimulation devices according to their approved instructions for use in routine clinical practice. Participants will first undergo a neurostimulation trial period using any commercially approved Boston Scientific neurostimulator for pain. Those who experience a positive outcome from this trial may then receive a permanent implant of the neurostimulation system. Treatment customization will be guided by the investigators judgment and routine care practices at each site. During the study, participants will be observed to collect information on clinical outcomes, technical device performance, and economic factors related to neurostimulation therapy. The research team will monitor participants over the long term to assess how well the therapy manages pain and its associated benefits. The study is expected to continue until May 2035, with ongoing follow-up and data collection throughout this period.