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.
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
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
OsteoRemedies, LLC
Lead sponsor
MCRA
Collaborator