Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections (NCT06428448) | Clinical Trial Compass
RecruitingPhase 2
Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
United States60 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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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
What they're measuring
1
Successful Treatment of Infection Based on Lab Values and Culture
✕. 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.