Study to Evaluate the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections
Recruiting
Phase 2Interventional Study
Periprosthetic Joint Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
OsteoRemedies, LLC · Industry
Who this trial is looking for
This trial is looking for adults with ankle-related infections to test a new treatment. Participants will receive the REMEDY SPECTRUM IM Spacer Nail and will need to complete some follow-up visits.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 21 years old
I have an ankle-related infection
I can give my written consent to participate
I am willing to follow the study procedures
If I am a woman who can get pregnant, I have a negative pregnancy test
You may not be able to join if
I have an infection that does not involve my ankle
I have a known immune deficiency
My affected limb has poor blood flow
I cannot have adequate soft-tissue coverage
I have a mental health disorder that affects my ability to participate
I am pregnant or breastfeeding
I am a prisoner
I have had an allergy to vancomycin or gentamicin
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Be ≥ 21 years of age
2. Have an ankle-related infection
3. Is skeletally mature, as evidenced by closed epiphyses.
4. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
5. Be willing and able to c…
Inclusion Criteria:
1. Be ≥ 21 years of age
2. Have an ankle-related infection
3. Is skeletally mature, as evidenced by closed epiphyses.
4. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
5. Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
6. 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:
1. Infections that do not involve the ankle
2. Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
3. Affected limb is dysvascular
4. Where adequate soft-tissue coverage cannot be achieved
5. Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
6. Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
7. Are currently a prisoner
8. 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.
9. History of vancomycin or gentamicin allergy
10. Are implanted with other antibiotic eluting products.
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