Actively Recruiting
Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
Led by OsteoRemedies, LLC · Updated on 2026-04-17
60
Participants Needed
3
Research Sites
95 weeks
Total Duration
On this page
Sponsors
O
OsteoRemedies, LLC
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial 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. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail.
CONDITIONS
Official Title
Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 21 years of age or older
- Have an ankle-related infection
- Be skeletally mature with closed epiphyses
- Be able to give voluntary, written informed consent
- Be willing and able to follow all study procedures before and after surgery
- If female and able to have children, have a negative pregnancy test before surgery and no plans to become pregnant until study completion
You will not qualify if you...
- Infection not involving the ankle
- Known immunodeficiency or recent immunosuppressive or radiation therapy within 6 months before surgery
- Dysvascular affected limb
- Inability to achieve adequate soft-tissue coverage
- Mental or psychological disorders impairing questionnaire completion
- Currently pregnant, breastfeeding, or planning pregnancy/breastfeeding during the study
- Currently a prisoner
- Medical or other conditions that could prevent follow-up visits or proper post-operative activity
- Allergy to vancomycin or gentamicin
- Implanted with other antibiotic eluting products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Michigan Health - Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48190
Actively Recruiting
2
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
Actively Recruiting
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Crystal Djaba
CONTACT
J
Jacob Schafer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here