Recruiting
Phase 2

REMEDY SPECTRUM IM Spacer Nail

Sponsor:

OsteoRemedies, LLC

Code:

NCT06428448

Conditions

Periprosthetic Joint Infection

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

REMEDY Spectrum IM Spacer Nail

Study Details

Brief 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. 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

Study ID

NCT06428448

Start date

Feb 1, 2026

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Subjects with REMEDY Spectrum IM Spacer Nail

This is the REMEDY Spectrum IM Spacer Nail treatment group.

Interventions

REMEDY Spectrum IM Spacer Nail

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.

Primary outcome measure

  • Successful Treatment of Infection Based on Lab Values and Culture [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan Health - Sparrow Clinical Research Institute

Recruiting

Lansing, Michigan, United States, 48190

Contacts

Principal Investigator:

Karl Dunn

OrthoCarolina Research Institute

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Principal Investigator:

Carroll Jones

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Karl Murawski

More Information

Sponsor

OsteoRemedies, LLC

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Ankle-related Infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OsteoRemedies, LLC on 2026-05-19.