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

Periprosthetic Joint Infection Clinical Trial

Official title:

A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06428448
• Other study ID #: SN-OR-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: OsteoRemedies, LLC
• Contact: Grace Montes
• Phone: 5712292683
• Email: gmontes[@]mcra.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Periprosthetic Joint Infection

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
OsteoRemedies, LLC	MCRA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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