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

NCT ID: NCT06428448

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-08-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects with REMEDY Spectrum IM Spacer Nail

This is the REMEDY Spectrum IM Spacer Nail treatment group.

Group Type: EXPERIMENTAL

REMEDY Spectrum IM Spacer Nail

Intervention Type: 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.

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.

Intervention Type: COMBINATION_PRODUCT

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 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MCRA

INDUSTRY

Sponsor Role: collaborator

OsteoRemedies, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel McGuire Kennedy

Role: STUDY_DIRECTOR

OsteoRemedies, LLC

Central Contacts

Grace Montes

Role: CONTACT

gmontes@mcra.com

5712292683

Jacob Schafer

Role: CONTACT

jschafer@mcra.com

Other Identifiers

SN-OR-001

Identifier Type: -

Identifier Source: org_study_id