Keller

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the outcomes of the Adductoplasty12 Procedure combined with the Lapiplastyae Procedure for patients needing correction of metatarsus adductus and hallux valgus. This prospective, multicenter, unblinded study will include up to 80 subjects aged 14 to 65 years across up to 13 clinical sites. The study aims to assess quality of life, pain scores, and the effectiveness of these procedures in correcting and maintaining the alignment of the first three metatarsals, the hallux position, sesamoid position, and foot width. Participants will receive treatment involving the combined Adductoplasty12 and Lapiplastyae Procedures. Eligible patients are those 14 years or older with symptomatic metatarsus adductus and hallux valgus who meet the defined criteria. The anticipated study duration is five years following the initial procedure, allowing for long-term evaluation of treatment outcomes. During the study, researchers will monitor radiographic recurrence of the hallux valgus deformity with metatarsus adductus at 24 months for those with successful correction. Participants will complete self-administered questionnaires to evaluate quality of life and pain. The study includes scheduled follow-up visits to assess anatomical alignment, patient-reported outcomes, and overall safety throughout the study period.