Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections

NCT06428448 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: SN-OR-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Keywords

Ankle-related Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

Subjects with REMEDY Spectrum IM Spacer Nail

EXPERIMENTAL

This is the REMEDY Spectrum IM Spacer Nail treatment group.

Combination Product: REMEDY Spectrum IM Spacer Nail

Interventions

REMEDY Spectrum IM Spacer Nail COMBINATION_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.

Subjects with REMEDY Spectrum IM Spacer Nail

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• OsteoRemedies, LLC: lead
• MCRA: collaborator

Study Sites (3)

University of Michigan Health - Sparrow Clinical Research Institute

Lansing, Michigan, 48190, United States

RECRUITING

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Study Officials

• Rachel McGuire Kennedy

  OsteoRemedies, LLC

  STUDY DIRECTOR

Central Study Contacts

Crystal Djaba

CONTACT

470-736-7850; cdjaba@mcra.com

Jacob Schafer

CONTACT

jschafer@mcra.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 24, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)