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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 31, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

August 31, 2026

Conditions
Periprosthetic Joint Infection
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."

All Listed Sponsors
collaborator

MCRA

INDUSTRY

lead

OsteoRemedies, LLC

INDUSTRY

NCT06428448 - Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections | Biotech Hunter | Biotech Hunter