Wiltrom Co., Ltd. is conducting a prospective multi-center Post-Market Clinical Follow-Up (PMCF) study across Germany for its innovative vertebral body augmentation system, Tripod-Fixยฎ. The study is expected to complete the one-year postoperative follow-up for all 53 enrolled patients.
To further validate the safety and long-term effectiveness of Tripod-Fix system in clinical use, Wiltrom launched this PMCF study in 2024 across three leading German medical institutions. The surgical procedures for all patients have been successfully completed, and the study is now entering the postoperative observation phase.
๐ง๐ต๐ฒ ๐๐ต๐ฟ๐ฒ๐ฒ ๐ฝ๐ฎ๐ฟ๐๐ถ๐ฐ๐ถ๐ฝ๐ฎ๐๐ถ๐ป๐ด ๐ฐ๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ถ๐๐ฒ๐ ๐ฎ๐ฟ๐ฒ:
๐๐ฟ๐ฎ๐ป๐ธ๐ฒ๐ป๐ต๐ฎ๐๐ ๐ ๐ฒ๐ฐ๐ต๐ฒ๐ฟ๐ป๐ถ๐ฐ๐ต (๐ ๐ฒ๐ฐ๐ต๐ฒ๐ฟ๐ป๐ถ๐ฐ๐ต ๐๐ผ๐๐ฝ๐ถ๐๐ฎ๐น)
A specialized institution in orthopedics and trauma care, playing a central role in this study with significant contributions to clinical operations and patient management.
๐๐น๐ถ๐ป๐ถ๐ธ๐๐บ ๐๐ฟ๐ถ๐ฒ๐ฑ๐ฟ๐ถ๐ฐ๐ต๐๐ต๐ฎ๐ณ๐ฒ๐ป
A major regional teaching hospital located in Friedrichshafen, Baden-Wรผrttemberg, known for its strong capabilities in trauma and orthopedic medicine and its active engagement in medical technology evaluations.
๐จ๐ป๐ถ๐ธ๐น๐ถ๐ป๐ถ๐ธ ๐ ๐ฎ๐ป๐ป๐ต๐ฒ๐ถ๐บ (๐จ๐ป๐ถ๐๐ฒ๐ฟ๐๐ถ๐๐ ๐๐ผ๐๐ฝ๐ถ๐๐ฎ๐น ๐ ๐ฎ๐ป๐ป๐ต๐ฒ๐ถ๐บ)
A key clinical center affiliated with Heidelberg University Medical Faculty, Uniklinik Mannheim is one of Germanyโs leading research hospitals, with extensive experience in international trials involving medical devices and implants.
Mechernich Hospital serves as a principal trial site and has been instrumental in data collection and clinical assessment throughout the study.
The full follow-up is projected to be completed by December 2025. The final results will contribute to the clinical evidence required not only under the European Union Medical Device Regulation (MDR) but by reimbursement reviews in major countries, providing healthcare professionals with robust data to support clinical decision-making regarding Tripod-Fix system.
