Vail

This research aims to assess the safety and performance of MagnetOs Putty and MagnetOs Easypack Putty, synthetic bone graft extenders, compared to autogenous bone graft in patients undergoing hindfoot or ankle fusions. The study focuses on treating hindfoot and ankle disorders requiring rigid hardware fixation and supplemental bone graft or substitute. It is a randomized, single-blind, controlled, multi-center phase IV post-marketing study involving adult patients aged 18 to 75 years. Participants will be randomly assigned to receive either MagnetOs PuttyEasypack Putty or autograft harvested from the calcaneus, distal tibia, or proximal tibia along with rigid hardware fixation during surgery. The volume used depends on the joint fused, with 1-5 cc for talonavicular, calcaneocuboid, and subtalar joints, and up to 10 cc for the tibiotalar joint. The surgical procedures include ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or double fusion of two of these joints. Participants will be followed up with radiographs at screening and weeks 6, 12, 24, and 52 post-surgery, with CT scans at weeks 24 and 52 to evaluate radiographic fusion. Functional assessments will also be conducted throughout the study period. If secondary surgical interventions occur after six months, CT scans may be adjusted. The primary outcome is radiographic fusion by CT scan at 24 weeks post-operation. Safety and efficacy are monitored for one year after surgery, with weight-bearing X-rays starting at week 12.

Researchers are evaluating a home-based leg dexterity training program to reduce pain and improve function in adults with knee osteoarthritis OA. This condition affects millions of older adults, causing pain and mobility issues. The study compares a new device, the Leg Dexterity System, designed to train neuromuscular control, against a commonly used wobble board exercise to see which better helps manage knee OA symptoms. The trial is a randomized, double-blind study involving 82 participants aged 40 to 85 years. Participants are randomly assigned to one of two groups one uses the Leg Dexterity device, a portable system where seated users compress a spring platform to train leg control the other uses a wobble board with safety rails for balance exercises. Both groups perform 10-minute training sessions three times a week for eight weeks at home. The sessions are guided and logged with a tablet-based app. Initial training and assessments occur at the research institute, with follow-up testing after the 8-week training period. Participants will be assessed before and after the training on knee pain using a numerical rating scale and the WOMAC pain and function scores. Additional measures include standing balance, physical function tests, gait analysis, and quality of life surveys. The study lasts about 10 weeks per participant, including baseline and follow-up visits. Researchers will monitor training adherence, safety, and the impact of the exercises on knee function and overall mobility.

Researchers are conducting the FLEX Registry, a large-scale, population-based study focusing on patients with stage I to III breast cancer who have undergone MammaPrint and BluePrint testing on their primary breast tumors. This observational registry aims to gather comprehensive full genome expression data linked with clinical information to explore new gene associations that may have prognostic or predictive value. The design is adaptive, allowing additional targeted substudies and arms to be added over time for more specific investigations. All participants will have their tumor samples tested using MammaPrint and BluePrint through the full-genome testing array provided by Agendia. Treatment decisions are made by the treating physician following NCCN guidelines or recognized alternatives, with no specific treatment mandated by the study. The registry plans to enroll about 30,000 patients from more than 125 US institutions, encompassing various treatment arms detailed in study appendices. Participants will have clinical data collected online at multiple time points at enrollment, during treatment, and at 1, 3, 5, and 10 years after diagnosis. This long-term follow-up allows researchers to study gene expression alongside clinical outcomes, supporting the creation of subgroup analyses and future targeted trials. The primary outcomes include establishing a large-scale full genome expression registry and providing infrastructure for examining smaller patient groups over the 10-year study period.

Researchers are evaluating the use of Losartan after total knee arthroplasty TKA to see if it can reduce or prevent arthrofibrosis, a condition that limits knee movement and affects clinical outcomes. This double-blind, randomized, placebo-controlled trial aims to assess the efficacy and safety of Losartan in improving patient-reported outcomes and reducing fibrosis, which will be measured by knee range of motion and thickness of the knee capsule. Participants will be randomly assigned to receive either Losartan 12.5 mg or a matching placebo twice daily for four weeks, starting the day after their knee replacement surgery. The study involves 120 patients undergoing primary TKA and includes two groups one taking Losartan and one taking placebo, both for the same duration and dosage. During the study, participants will undergo assessments at baseline, 6 weeks, and 3 months after surgery. These include ultrasound measurements of knee capsule thickness, knee range of motion, blood tests for immune and growth factor markers, strength testing, and patient questionnaires about pain and health status. Safety will be monitored throughout the study, which lasts approximately 3.5 months from the start of dosing.

Researchers are evaluating the outcomes of common surgeries for patients with acute or recurrent anterior shoulder instability who have subcritical bone loss of 10-20%. The study focuses on military personnel and civilians aged 17 to 50 who have experienced traumatic anterior shoulder dislocation. The goal is to understand how different surgical options affect recovery, return to work, sports, and physical function over time. The study compares three surgical procedures arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart repair, and the Latarjet procedure. All participants will receive post-operative rehabilitation tailored to their surgery. The choice of surgery is made jointly by the patient and surgeon. Participants will be followed for 24 months to track outcomes. Participants will undergo imaging scans such as CT or 3D-MRI to measure bone loss and confirm eligibility. Researchers will collect data at multiple time points up to two years after surgery, including patient-reported physical function scores, time to return to pre-injury activities, and any recurrent instability or re-injury events. Additional assessments include range of motion, muscle strength, functional tests, pain, medication use, and quality of life measures. This extensive monitoring aims to identify factors that influence recovery and long-term success.