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

ConditionPeriprosthetic Joint Infection

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age21+

SponsorOsteoRemedies, LLC

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

REMEDY Spectrum IM Spacer Nail
Combination product
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.

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: Subjects with REMEDY Spectrum IM Spacer NailExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Successful Treatment of Infection Based on Lab Values and Culture

Healed wound and no infection recurrence caused by the same organism strain infection for duration of two weeks post antibiotic regimen.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OsteoRemedies, LLC

Lead sponsor

MCRA

Collaborator

Source ClinicalTrials.gov

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