NCT06428448 · OsteoRemedies, LLC
Study to Evaluate the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Lansing, Michigan
- Charlotte, North Carolina
- Durham, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations