Periprosthetic Joint InfectionPhase 2NCT06428448
Study to Evaluate the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections
A Phase 2 study testing REMEDY Spectrum IM Spacer Nail in people with Periprosthetic Joint Infection, run by OsteoRemedies, LLC at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periprosthetic Joint Infection
- What is being tested?
- REMEDY Spectrum IM Spacer Nail
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Infections that do not involve the ankle
- Have a known immunodeficiency; including subjects 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
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- 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, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities.
- History of vancomycin or gentamicin allergy
- Are implanted with other antibiotic eluting products.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jacob Schafer contact
United States3 sites, 3 recruiting
- Recruiting
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Zachary Hutchko, 704-323-2556, Zachery.Hutchko@orthocarolina.com
Caleb Michalek, 7043233698, Caleb.Michalek@orthocarolina.com
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Caroline Darragh, 919-613-3670, caroline.darragh@duke.edu
Karl Murawski
- Recruiting
University of Michigan Health - Sparrow Clinical Research Institute
Lansing, Michigan, 48190
Jennifer Boak, 517-364-5733, Jennifer.Boak@UofMHealth.org
Jessica Bristol-Piper, 517-364-5728, Jessica.Bristol-Piper@UMHSparrow.org
About this study
Official title: 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
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
- Periprosthetic Joint Infection
- Being tested
- REMEDY Spectrum IM Spacer Nail
- Keywords
- Ankle-related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMEDY Spectrum IM Spacer NailCombination product
The REMEDY SPECTRUM IM Spacer Nail is a single-use implant made of polymethylmethacrylate (PMMA) which is internally reinforced with a stainless-steel core (ASTM F138, ISO 5832-1). The PMMA of the REMEDY SPECTRUM IM Spacer Nail is laden with gentamicin and vancomycin.
The nail has a slot at the distal end and can be combined with the surgeon's choice of fixation to prevent migration depending on the anatomy of the patient. The REMEDY SPECTRUM IM Spacer Nail is available in two lengths (150mm and 300mm) to accommodate variations in patient anatomy. The distal end has a threaded recess for mating with the optional distal cap, as well as the insertion and removal tools.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with REMEDY Spectrum IM Spacer Nail | Experimental | This is the REMEDY Spectrum IM Spacer Nail treatment group. Receives: Combination Product: REMEDY Spectrum IM Spacer Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Treatment of Infection Based on Lab Values and Culture
Healed wound and no infection recurrence caused by the same organism strain infection for duration of two weeks post antibiotic regimen.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OsteoRemedies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Rachel McGuire Kennedy, Study director, OsteoRemedies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428448
- Sponsor's protocol ID
- OR-SN-001
- Status last verified
- May 2026
- First submitted
- 17 May 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06428448
- Acronym / sponsor ID
- OR-SN-001
- Conditions
- Periprosthetic Joint Infection
- Keywords
- Ankle-related Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- OsteoRemedies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with REMEDY Spectrum IM Spacer Nail | Experimental | Combination Product: REMEDY Spectrum IM Spacer NailThis is the REMEDY Spectrum IM Spacer Nail treatment group. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Infections that do not involve the ankle
- Have a known immunodeficiency; including subjects 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMEDY Spectrum IM Spacer NailThe REMEDY SPECTRUM IM Spacer Nail is a single-use implant made of polymethylmethacrylate (PMMA) which is internally reinforced with a stainless-steel core (ASTM F138, ISO 5832-1). The PMMA of the REMEDY SPECTRUM IM Spacer Nail is laden with gentamicin and vancomycin. The nail has a slot at the distal end and can be combined with the surgeon's choice of fixation to prevent migration depending on the anatomy of the patient. The REMEDY SPECTRUM IM Spacer Nail is available in two lengths (150mm and 300mm) to accommodate variations in patient anatomy. The distal end has a threaded recess for mating with the optional distal cap, as well as the insertion and removal tools. | Combination product | Subjects with REMEDY Spectrum IM Spacer Nail |
Primary outcome
Successful Treatment of Infection Based on Lab Values and Culture
Time frame: 6 months
Healed wound and no infection recurrence caused by the same organism strain infection for duration of two weeks post antibiotic regimen.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob Schafer contact
Rachel McGuire Kennedy study director
OsteoRemedies, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REMEDY Spectrum IM Spacer Nail in people with Periprosthetic Joint Infection, run by OsteoRemedies, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Djaba (470-736-7850, cdjaba@mcra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Treatment of Infection Based on Lab Values and Culture (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.