RecruitingPhase 2NCT06428448

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

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

Sponsor

OsteoRemedies, LLC

Enrollment

60 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Periprosthetic Joint Infection

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria6

Be ≥ 21 years of age
Have an ankle-related infection
Is skeletally mature, as evidenced by closed epiphyses.
Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant until study completion.

Exclusion Criteria10

Infections that do not involve the ankle
Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
Affected limb is dysvascular
Where adequate soft-tissue coverage cannot be achieved
Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
Are currently a prisoner
Have any medical condition or other circumstances, in the judgment of the Investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities.
History of vancomycin or gentamicin allergy
Are implanted with other antibiotic eluting products.

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Interventions

COMBINATION_PRODUCTREMEDY 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.