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New treatment option for Periprosthetic Joint Infection
Official title Study to Evaluate the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections
ClinicalTrials.gov ID: NCT06428448
What this study is testing
What is REMEDY Spectrum IM Spacer Nail?
REMEDY Spectrum IM Spacer Nail is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for periprosthetic joint infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Infections that do not involve the ankle
- Have a known immunodeficiency; including people who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy...
- 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
See the full eligibility 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.
- Infections that do not involve the ankle
- Have a known immunodeficiency; including people 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...
- History of vancomycin or gentamicin allergy
- Are implanted with other antibiotic eluting products.
The study team makes the final eligibility decision.
Where it's taking place
- Lansing, Michigan, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lansing, Michigan, United States; Charlotte, North Carolina, United States; Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.