Willoughby

This research aims to compare two surgical treatments for patients with irreparable rotator cuff tears, a challenging shoulder injury. The study evaluates pain and functional outcomes using several measures including the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and PROMIS-29 score at multiple time points up to 24 months after surgery. It also investigates the failure rates of the treatments using MRI scans at 12 months post-operation. The goal is to understand if adding superior capsular reconstruction (SCR) to partial rotator cuff repair provides any benefit over partial repair alone. Participants will be randomly assigned to one of two groups: one receiving partial rotator cuff repair alone, and the other receiving partial rotator cuff repair combined with superior capsular reconstruction using acellular dermal allograft. Both surgeries may include other procedures such as subacromial decompression and biceps tenodesis. Surgery will be performed after medical clearance, and intraoperative data such as repair techniques and any complications will be recorded. Patients will follow an identical post-operative care plan and medication regimen. Throughout the study, participants will attend follow-up visits at 6 weeks, 3, 6, 12, and 24 months after surgery. At each visit, pain and shoulder function will be assessed using the VAS, SST, ASES, and PROMIS-29 questionnaires, and any complications will be noted. An MRI will be performed at 12 months to assess repair integrity. Researchers will collect data including demographics, injury details, and surgical outcomes to evaluate differences between the two surgical approaches over the two-year period.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating a stepped care approach called STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) to reduce suicide risk among youth aged 12 to 17 years receiving primary care. This study aims to compare the effectiveness of STARRS-PC against usual treatment (TAU) in lowering suicide attempts, suicidal thoughts, and self-injury over a 12-month period. The study also explores factors that affect how well the clinical pathway can be put into practice and sustained in primary care settings. The study is conducted over five years at 14 pediatric primary care clinics. It includes three phases: treatment as usual (TAU), intervention, and sustainability. During TAU, usual depression and suicide risk screening is performed. In the intervention phase, STARRS-PC is implemented, which involves universal suicide risk screening with a brief questionnaire, followed by a detailed risk assessment and care decisions based on risk level. Providers receive training and participate in interviews to identify challenges and supports for implementing the clinical care pathway. The final sustainability phase focuses on maintaining improvements without enrolling new participants. Participants include 2,572 adolescents identified at risk for suicide along with their parents or guardians. They complete interviews and questionnaires at baseline, 3, 6, and 12 months. Medical records are reviewed throughout the study. Youth outcomes measured include suicide attempts, suicidal thoughts, and non-suicidal self-injury, while family satisfaction is also assessed. Providers are evaluated on knowledge and attitudes about suicide risk management. The study includes ongoing monitoring, data collection, and a 6-month follow-up after the intervention phase for sustainability analysis.