drugset / Trial / NCT06428448

Study to Evaluate the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections

NCT06428448

Phase 2 Recruiting 60 enrolled OsteoRemedies, LLC MCRA · collab
NaSingle-groupOpen-labelTreatment

Summary

This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail.

Timeline

Start
2026-02-01
Primary completion
2027-08
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Background Gentamicin Small molecule
Background Vancomycin Other / unclassified