Evaluating Safety and Effectiveness of Inion CompressOn Bioabsorbable Screws in Foot and Ankle Fracture and Surgery

What this Trial Is About

Researchers are evaluating the safety and performance of the bioabsorbable headless compression screw called Inion CompressOn in certain foot and ankle surgeries involving fractures, osteotomies, and arthrodeses. This study focuses on adult patients undergoing these operations and aims to assess bone healing and the occurrence of any adverse events or revision surgeries related to the device. The study is conducted as a single-center, single-group investigation at Tampere University Hospital in Finland. The Inion CompressOn screws are made from degradable polymers that maintain their strength for up to 12 weeks after implantation and gradually absorb within two to four years. The devices are used during surgical bone fixation operations for various foot and ankle injuries and deformities, such as medial malleolar fractures, Lisfranc injuries, talus and calcaneal fractures, and several types of arthrodesis and osteotomies. All 125 participants receive surgery using these screws, with follow-up visits planned for up to four years after the operation. Participants will undergo six follow-up visits, starting with a screening visit before surgery, the operation itself, and several post-operative visits at 6 weeks, 3 months, 2 years, and 4 years. The first four visits align with standard care, while the last two are study-specific to gather long-term safety and performance data. Researchers will assess bone healing, adverse events, revision surgeries, wound healing, fixation strength, and patient-reported foot and ankle function over this period.

Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation