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

Launched by OSTEOREMEDIES, LLC · May 22, 2024

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be ≥ 21 years of age
• • 2. Have an ankle-related infection
• • 3. Is skeletally mature, as evidenced by closed epiphyses.
• • 4. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• • 5. Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
• • 6. 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:
• • 1. Infections that do not involve the ankle
• • 2. Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
• • 3. Affected limb is dysvascular
• • 4. Where adequate soft-tissue coverage cannot be achieved
• • 5. Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
• • 6. Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
• • 7. Are currently a prisoner
• • 8. 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.
• • 9. History of vancomycin or gentamicin allergy
• • 10. Are implanted with other antibiotic eluting products.

Trial Officials