Actively Recruiting
A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections
Led by OsteoRemedies, LLC · Updated on 2026-05-19
60
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
Sponsors
O
OsteoRemedies, LLC
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in treating infections related to the ankle. This prospective, multicenter, single-arm clinical trial focuses on adults aged 21 and older who have ankle-related infections. The study is sponsored by OsteoRemedies, LLC and is expected to last about 18 months, including a 12-month enrollment period and a 6-month follow-up. All participants will receive the REMEDY SPECTRUM IM Spacer Nail, a single-use implant made of polymethylmethacrylate reinforced with a stainless-steel core and loaded with antibiotics gentamicin and vancomycin. The nail is available in two lengths to fit different patient anatomies and is combined with surgical fixation as needed to prevent migration. The study involves surgical implantation of this device. During the study, participants will undergo pre-operative and post-operative procedures while being monitored for infection treatment success based on laboratory values and cultures over a 6-month period. Researchers will assess the resolution of infection and monitor participants for safety and effectiveness of the implant. The total participation time is approximately 18 months from enrollment through follow-up.
CONDITIONS
Brief Title
Study to Evaluate the REMEDY SPECTRUM GV 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 comply with all study procedures
- If female and of child-bearing potential, have a negative pregnancy test before surgery and no plans to become pregnant during the study
You will not qualify if you...
- Have infections that do not involve the ankle
- Have a known immunodeficiency or recent immunosuppressive treatment within 6 months
- Have a dysvascular affected limb
- Lack adequate soft-tissue coverage
- Have mental or psychological disorders impairing study participation
- Are currently pregnant, breastfeeding, or planning pregnancy during the study
- Are currently a prisoner
- Have medical or other conditions that prevent follow-up or post-operative activities
- Have a history of allergy to vancomycin or gentamicin
- Are implanted with other antibiotic eluting products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 weeks or until discharge
Participants undergo surgery to receive the REMEDY Spectrum IM Spacer Nail implant and immediate post-operative care.
1 surgery visit and several in-person post-operative visits
Duration - 6 months
Participants are monitored after surgery to evaluate the treatment effectiveness and safety, including lab values and culture assessments.
Regular visits over 6 months
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
J
Jacob Schafer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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