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

Inclusion criteria

• 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 criteria

• 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.