Mechernich

Researchers are evaluating the safety and effectiveness of the VCFix Spinal System, a medical device designed to treat specific spinal fractures called vertebral compression fractures VCFs in adults aged 21 to 85 years. This study involves up to 8 hospitals in Europe and aims to assess how well the device works and how safe it is for patients with these fractures. The study compares two groups one receiving the VCFix implant with bone cement and the other without cement. Participants will receive the VCFix device implant either with or without the use of PMMA bone cement, according to their assigned study group. The device features in situ adjustment to realign vertebrae, a titanium structure allowing natural bone healing, and the potential to stabilize severe fractures through a pedicle screw component. Treatment will follow intended use guidelines, and researchers will monitor outcomes including pain reduction, function improvement, and device-related complications. During the study, participants will be assessed for changes in back pain and daily functioning at 6 months compared to before treatment. Additional measures include vertebral height restoration, spinal angle improvements, and health-related quality of life at various time points up to 24 months. Safety will be monitored through serious adverse device effects during the first month and adverse events up to two years. The total participation duration extends through follow-up assessments to evaluate both effectiveness and safety.

Shoulder pain is a common problem that affects daily activities, work, sports, and independence. Rotator cuff disease is the main cause of shoulder pain and accounts for up to 70% of shoulder-related doctor visits. This condition includes various issues like tendinopathy, bursal problems, and rotator cuff tears RCTs, which often happen due to trauma or degenerative changes, especially in middle-aged or older adults. The study focuses on adult patients with rotator cuff tears up to 2 cm in size to better understand and treat these injuries. The trial compares two surgical methods for repairing rotator cuff tears using the SINEFIX implant and instruments versus a conventional surgical technique. The SINEFIX system was previously tested in a pilot study and is now being evaluated in a larger group. Participants will be randomly assigned to receive one of these two repair methods. Both treatments involve arthroscopic surgery aimed at reconstructing the rotator cuff. Participants will be followed for up to two years after surgery, with evaluations at multiple time points including 10 weeks, 6 months, 1 year, and 2 years. Researchers will assess shoulder function through physical exams and patient questionnaires, monitor healing and implant status using imaging, and record complications, re-tear rates, and patient satisfaction. The main outcome measured is the functional and clinical improvement one year after surgery compared to before the operation.