Vail

Researchers are evaluating the safety and performance of MagnetOs Putty and MagnetOs Easypack Putty compared to autogenous bone graft in patients undergoing hindfoot or ankle fusion surgeries. This phase IV post-marketing study focuses on treating hindfoot and ankle disorders using these synthetic bone graft extenders or autograft material, both combined with rigid hardware fixation. The study aims to assess how well these treatments support bone fusion in various fusion procedures including ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or combinations of these. Approximately 126 adult patients aged 18 to 75 will be randomly assigned to receive either MagnetOs Putty/Easypack Putty or autograft from the calcaneus, distal tibia, or proximal tibia during their fusion surgery. The volume used depends on the fusion site, with 1-5 cc for smaller joints and up to 10 cc for the tibiotalar joint. The surgical procedures use rigid fixation with screws, plates, staples, nails, or combinations thereof. Treatments will be applied according to approved instructions for use. Following surgery, patients will be monitored over a year with scheduled visits at discharge and weeks 2, 6, 12, 24, and 52. Throughout the study, patients will undergo radiographic imaging at screening and weeks 6, 12, 24, and 52, with CT scans at weeks 24 and 52 to assess bone fusion. Weight-bearing X-rays will begin at week 12. Researchers will track the primary outcome of radiographic fusion via CT scan at 24 weeks post-operation. Additional follow-up will monitor safety and effectiveness for one year. If patients require secondary surgical intervention after 6 months, further CT scans may be omitted. The study collects detailed imaging, clinical evaluations, and safety data during this period.

Researchers are studying adults aged 40 to 85 who have knee osteoarthritis, a condition that causes pain and limits movement. The study aims to compare the effects of a home-based leg dexterity training device with traditional wobble board exercises. Knee osteoarthritis is a complex disease involving pain, joint damage, and movement issues, and current nonsurgical treatments include exercise and medication. This trial explores if the new Leg Dexterity System can better reduce pain and improve function compared to standard exercises. Participants will be randomly assigned to one of two groups: one using the Leg Dexterity Trainer and the other using a wobble board. The Leg Dexterity device is portable and wireless; participants sit and press a platform on a spring that becomes unstable, requiring control of leg movements. The wobble board involves standing balance exercises with safety bars for support. Both groups will train at home three times a week for eight weeks. Participants start with a baseline visit for consent, assessment, and training on their assigned device. After eight weeks of home training, they return for follow-up testing and to return the equipment. Researchers will measure pain using the Numerical Rating Scale and WOMAC scores, as well as function through various physical tests. The total participation time is about ten weeks, with safety and progress monitored throughout.

Researchers are conducting the FLEX Registry to study patients with stage I to III breast cancer who receive MammaPrint and BluePrint testing on a primary breast tumor. This large-scale, population-based, prospective registry aims to create a comprehensive database of full genome expression linked with clinical data to explore new gene associations that may have prognostic or predictive value. The registry uses an adaptive design, allowing additional targeted substudies and arms to be added over time. The study involves patients from over 125 U.S. institutions, with an anticipated enrollment of around 30,000 participants. Treatment decisions are made by physicians following NCCN-approved regimens or recognized alternatives. MammaPrint and BluePrint tests are performed by Agendia using the full genome testing array. Data collection occurs at enrollment, during treatment, and at follow-up intervals of 1, 3, 5, and 10 years after diagnosis. Participants will have clinical data entered online at specified time points, with the goal of generating hypotheses for targeted subset analyses and further trials based on the genetic data collected. Outcome measures include the creation of a large registry for gene expression and clinical data over 10 years and the development of shared registry infrastructure to study smaller patient groups. This is an observational phase IV study focused on long-term data gathering and analysis.

Researchers are evaluating the use of Losartan after total knee arthroplasty (TKA) to see if it can reduce or prevent arthrofibrosis, a condition that causes joint stiffness and affects recovery. This double-blind, randomized, placebo-controlled clinical trial involves 120 patients undergoing primary total knee replacement to study Losartan's safety and effectiveness in improving outcomes and reducing fibrosis. Participants will be randomly assigned to receive either 12.5 mg oral Losartan or a placebo tablet daily for 28 days after surgery. Fibrosis will be monitored through measures such as knee range of motion and capsular thickness using quantitative ultrasound at baseline, 6 weeks, and 3 months after surgery. The study is conducted at The Steadman Clinic and includes two phases to carefully assess treatment effects. Throughout the study, patients will undergo various assessments, including ultrasound scans and range of motion tests at specified time points. Researchers will track how the knee heals, measure changes in capsular thickness, and evaluate functional recovery. Safety and patient-reported outcomes will also be monitored over the 3-month follow-up period to understand the impact of Losartan post-surgery.

Researchers are evaluating the outcomes of common surgical treatments for patients with traumatic anterior shoulder instability who have subcritical bone loss (10-20% of the glenoid width). This study focuses on military personnel and civilians aged 17 to 50 who have had an anterior shoulder dislocation and are undergoing one of three surgeries: arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart repair, or Latarjet procedure. The goal is to understand how these surgeries combined with post-operative rehabilitation affect recovery and return to physically demanding activities over time. Participants will receive one of the three specified surgical procedures determined through shared decision-making with their surgeon. Following surgery, they will undergo post-operative rehabilitation tailored to their specific procedure and individual needs. This rehabilitation aims to improve range of motion, strength, and overall shoulder function. The study follows participants for 24 months after surgery to track recovery progress and identify factors that influence successful outcomes. During the study, participants will be regularly assessed using the Western Ontario Shoulder Instability Index (WOSI) at 3, 6, 12, and 24 months after surgery. Researchers will also monitor the time it takes for participants to return to their pre-injury levels of military duty, work, or sports, as well as record any recurrent shoulder instability or re-injury during this period. Additional information on rehabilitation participation and patient-reported physical function will be collected to help predict long-term recovery and quality of life.