REMEDY SPECTRUM intramedullary spacer nail for ankle infections
A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
This trial will test the REMEDY SPECTRUM intramedullary spacer nail in adults with ankle-related infections to see if it is safe and helps treat the infection.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | OsteoRemedies, LLC Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Lansing, Michigan and 2 other locations) |
| Trial ID | NCT06428448 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, single-arm Phase 2 study in which all enrolled adults with ankle-related infections will receive the REMEDY SPECTRUM intramedullary (IM) spacer nail. Subjects will be enrolled over approximately 12 months with a 6-month post-operative follow-up, for an expected total duration of about 18 months. The study will collect surgical, clinical, and infection-related outcomes to determine device safety and effectiveness for local stabilization and antibiotic delivery in the ankle. Key eligibility requires adults ≥21 years with ankle infection, sufficient soft-tissue coverage and vascular status, and the ability to consent and comply with follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 or older with an ankle-related infection who have adequate soft-tissue coverage and vascular supply and who can undergo surgery and follow-up.
Not a fit: Patients whose infection does not involve the ankle, who have a dysvascular limb, inadequate soft-tissue coverage, known immunodeficiency, or inability to undergo or comply with surgery and follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could improve local infection control and ankle stability, potentially reducing the need for additional surgeries or amputation.
How similar studies have performed: Antibiotic-loaded spacer nails and spacers have shown benefit for long-bone and joint infections, but use of this specific REMEDY SPECTRUM IM spacer nail for ankle infections is relatively novel and has limited published data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lansing, Michigan and 2 other locations
- University of Michigan Health - Sparrow Clinical Research Institute — Lansing, Michigan, United States (Recruiting)
- OrthoCarolina Research Institute — Charlotte, North Carolina, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Crystal Djaba
- Email: cdjaba@mcra.com
- Phone: 470-736-7850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.