Study of the Lync Device to Treat Arthritis and Correct Bone Misalignment in Toes

What this Trial Is About

This research evaluates the Lync4 device implanted in the toes to treat arthritis and correct bone misalignments such as mallet toes, claw toes, and hammer toes. The study aims to confirm the clinical benefits, performance, and safety of this device by assessing how well it restores forefoot function at 3 to 4 months after surgery using the AOFAS-LMIS score. Participants receive treatment with the Lync4 intramedullary osteosynthesis device, which is implanted in the toes to address arthritis and bone alignment issues. The study monitors patients primarily at 3 to 4 months post-operation, with additional follow-ups if bone healing is incomplete. Secondary evaluations include pain reduction using the Visual Analogue Scale VAS, bone consolidation through radiographic exams, and monitoring for any adverse events or device defects throughout the study. During the study, participants will have clinical and radiographic assessments of their foot at 3 to 4 months after surgery, with an extra visit at 6 months if needed to confirm bone healing. Researchers will track pain levels, functional recovery, and safety outcomes, including any complications or device problems. The entire follow-up averages about 6 months, ensuring thorough monitoring of treatment effects and safety.

Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync