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Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
Sponsor: OsteoRemedies, LLC
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.
Official title: A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-08
Completion Date
2026-08
Last Updated
2024-05-30
Healthy Volunteers
Yes
Conditions
Interventions
REMEDY Spectrum IM Spacer Nail
The REMEDY SPECTRUM IM Spacer Nail is a single-use implant made of polymethylmethacrylate (PMMA) which is internally reinforced with a stainless-steel core (ASTM F138, ISO 5832-1). The PMMA of the REMEDY SPECTRUM IM Spacer Nail is laden with gentamicin and vancomycin. The nail has a slot at the distal end and can be combined with the surgeon's choice of fixation to prevent migration depending on the anatomy of the patient. The REMEDY SPECTRUM IM Spacer Nail is available in two lengths (150mm and 300mm) to accommodate variations in patient anatomy. The distal end has a threaded recess for mating with the optional distal cap, as well as the insertion and removal tools.