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NOT YET RECRUITING
NCT06428448
PHASE2

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

Sponsor: OsteoRemedies, LLC

View on ClinicalTrials.gov

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

Interventions

COMBINATION_PRODUCT

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.