REMEDY Spectrum IM Spacer Nail for Ankle Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail for treating ankle infections. The trial will last about 18 months, with participants monitored for 6 months after treatment. All participants will receive the same treatment with the spacer nail. It is suitable for individuals over 21 with an ankle infection. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.
What prior data suggests that the REMEDY SPECTRUM IM Spacer Nail is safe for treating ankle infections?
Research has shown that antibiotic cement spacers, such as the REMEDY SPECTRUM IM Spacer Nail, are generally safe. Studies have found these spacers effectively treat bone infections, including those in the ankle, with a success rate of 88% to 100% in eliminating infections. Patients often find these spacers comfortable, enabling earlier walking and reducing the need for additional procedures like bone grafts.
Occasionally, implants may need removal if infections persist, a common occurrence with such treatments and not specific to the REMEDY SPECTRUM. Overall, evidence suggests this treatment is well-tolerated and effective in combating bone infections.12345Why do researchers think this study treatment might be promising?
Most treatments for ankle infections involve antibiotics and sometimes surgical removal of infected tissue. But the REMEDY Spectrum IM Spacer Nail works differently, targeting the infection directly within the bone. It's designed to release antibiotics locally, which can help concentrate the treatment right where it's needed most, potentially improving effectiveness and reducing side effects compared to systemic antibiotic treatments. Researchers are excited because this method could lead to faster recovery and less invasive procedures for patients suffering from ankle infections.
What evidence suggests that the REMEDY SPECTRUM IM Spacer Nail is effective for ankle infections?
Research has shown that treatments like the REMEDY Spectrum IM Spacer Nail, studied in this trial, are coated with antibiotics and effectively fight infections. Studies found that these antibiotic-coated rods eliminated infections in 85.71% of patients. Additionally, 69.1% of patients recovered quickly after just one procedure. For infections in the ankle and long bones, these treatments have successfully stabilized the bone and mostly eradicated the infection. Using these antibiotic-coated nails has also resulted in a high success rate for saving limbs from severe infection, with 93.7% of cases being successful. Overall, this evidence suggests that the REMEDY Spectrum IM Spacer Nail could be a strong option for treating ankle infections.678910
Who Is on the Research Team?
Rachel McGuire Kennedy
Principal Investigator
OsteoRemedies, LLC
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the REMEDY SPECTRUM IM Spacer Nail for the treatment of ankle-related infections
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- REMEDY SPECTRUM IM Spacer Nail
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This is the REMEDY Spectrum IM Spacer Nail treatment group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
OsteoRemedies, LLC
Lead Sponsor
MCRA
Industry Sponsor
Citations
Treatment of chronic osteomyelitis with antibiotic-impregnated ...
The purpose of this study was to evaluate the outcome of using ACSs in the form of beads, rods, intramedullary nails, or blocks as definitive management for ...
Effectiveness of Antibiotic Cement-Coated Rods in the ... - PMC
Treatment was effective in 108 patients (85.71%), while 18 patients (14.29%) experienced persistence or recurrence of infection. Pain relief ...
(PDF) Efficacy of Infection Eradication in Antibiotic Cement- ...
Additionally, 69.1% (n = 67) of healed patients were resolved after only one procedure, and the remainder (30.9%, n = 30) healed after one or ...
4.
acfas.org
acfas.org/getattachment/c7748cbf-0450-4c2a-b7de-c3fd14655574/POST2018_CS-1041.pdf?lang=en-USAntibiotic Coated Intramedullary Nail for Ankle Fusion in ...
In the case of nonunion and osteomyelitis in the setting of OI, application of. IM nail coated with antibiotic cement can be successful in maintaining position ...
Antibiotic Impregnated Cement Coated Intramedullary ...
Antibiotic impregnated cement coated intramedullary nailing is a very good and effective treatment for infected nonunion and chronic osteomyelitis long bones.
6.
osteoremedies.com
osteoremedies.com/wp-content/uploads/2019/05/Z1G130_0519_REMEDY-REMEDY-SPECTRUM-Patient-IFU-1.pdfremedy® & remedy spectrum® gv hip spacers
Your doctor will need to have complete and accurate information on your health status in order to decide whether the REMEDY® Hip Spacer or the REMEDY SPECTRUM®.
7.
researchgate.net
researchgate.net/publication/352542456_Outcomes_of_Various_Antibiotic_Cement_Coated_Intramedullary_Implants_on_the_Treatment_of_Long_Bone_Septic_NonunionOutcomes of Various Antibiotic Cement Coated ...
Patients treated with a rigid, locked antibiotic nail achieved earlier weight bearing (p = 0.001), less frequently required autograft (p = 0.005) ...
8.
acfas.org
acfas.org/getattachment/223c8ed3-45d3-4bcb-9997-2f9054463ee1/POST2018_SCI-1019.pdf?lang=en-USOutcomes and Management of Infected Intramedullary ...
The purpose of the current study is to report on the outcomes of patients undergoing revision of infected tibiotalocalcaneal arthrodesis (TTCA) for limb ...
9.
journals.lww.com
journals.lww.com/otainternational/fulltext/2021/06001/cement_beads_and_cement_spacers__indications,.3.aspxCement beads and cement spacers: indications, ...
An antibiotic impregnated cement nail (ACN) fills the dead space and elutes high concentrations of antibiotics providing some mechanical stability.
Permanent antibiotic impregnated intramedullary nail in ...
IM nailing of closed tibial fractures has an associated infection rate of approximately 1% (16). The infection rate is expected to be significantly higher in ...
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