Overview
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
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.
