Broomfield

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 evaluating two platelet-based treatments spaced four weeks apart compared to sham procedures for treating painful lumbar degenerative disc disease. This single-blind, randomized, placebo-controlled study aims to observe improvements in patient-reported outcomes from baseline to three months after the second treatment, with ongoing assessment of effectiveness and durability up to twelve months. The study includes adults aged 25 to 65 years with confirmed degenerative disc disease who have not responded to prior conservative treatments. Participants receive either two treatments involving platelet-rich plasma, platelet lysate, and platelet poor plasma injections into specific areas of the lumbar spine or two sham procedures mimicking the treatment without injecting any substances. The treatments involve drawing and processing the patients blood, followed by ultrasound or x-ray guided injections into the multifidus muscle, epidural space, facet joints, tendon insertions, and ligaments at the affected spinal levels. The sham group undergoes needle placements without injections. After three months, patients in the sham group may crossover to receive the real treatment and continue follow-up accordingly. Participants attend a pretreatment visit at or before enrollment, with follow-up visits at three and twelve months post-injection. They complete questionnaires assessing pain and function at one, three, six, and twelve months. Researchers measure outcomes including pain scales, functional indexes, disability scores, medication use, adverse events, and additional treatments. The total participation lasts up to one year with ongoing monitoring of clinical outcomes and safety throughout the study period.

Researchers are evaluating a new approach to treat injuries of the alar, accessory, and transverse ligaments in patients with craniocervical junction CCJ instability. This study aims to assess the safety and effectiveness of using an anterior approach through the posterior oropharynx combined with bone marrow concentrate therapy. The trial is a single-center, randomized, controlled study that compares two bone marrow concentrate treatments to two sham procedures in patients suffering from symptoms related to CCJ instability, including headaches and dizziness. Participants in the treatment group will undergo bone marrow aspiration from the posterior iliac crest to prepare platelet rich plasma and platelet lysate mixed with bone marrow cells. Under anesthesia, this mixture will be injected into the injured ligaments using fluoroscopy and endoscopic guidance through the posterior oropharynx. Patients will also receive injections to upper cervical ligaments and facets. The control group will receive similar bone marrow aspiration but will undergo sham injections designed to mimic the procedure without the active treatment. Both groups will receive two procedures spaced three months apart. Throughout the study, patients will be assessed using clinical outcome questionnaires and digital motion X-rays at three months following the second procedure. Outcomes include changes in headache impact, neck disability, pain levels, and physical function. Safety will also be monitored through adverse event tracking for six months after treatment. Control participants may opt to receive the active treatment after the initial evaluation period. The total study duration extends up to 2030, with ongoing monitoring and evaluation.