## Protocol Section
### Identification Module
**NCT ID:** NCT06428448

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

**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

#### Organization Study ID Info
**ID:** SN-OR-001
#### Organization
**Class:** INDUSTRY
**Full Name:** OsteoRemedies, LLC
### Status Module
#### Completion Date
**Date:** 2026-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** MCRA

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** OsteoRemedies, LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** True

**Is Unapproved Device:** True

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Periprosthetic Joint Infection

**Keywords:**

- Ankle-related Infections

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This is the REMEDY Spectrum IM Spacer Nail treatment group.

**Intervention Names:**

- Combination Product: REMEDY Spectrum IM Spacer Nail

**Label:** Subjects with REMEDY Spectrum IM Spacer Nail

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Subjects with REMEDY Spectrum IM Spacer Nail

**Description:** 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.

**Name:** REMEDY Spectrum IM Spacer Nail

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** Healed wound and no infection recurrence caused by the same organism strain infection for duration of two weeks post antibiotic regimen.

**Measure:** Successful Treatment of Infection Based on Lab Values and Culture

**Time Frame:** 6 months

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gmontes@mcra.com

**Name:** Grace Montes

**Phone:** 5712292683

**Role:** CONTACT

**Contact 2:**

**Email:** jschafer@mcra.com

**Name:** Jacob Schafer

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** OsteoRemedies, LLC

**Name:** Rachel McGuire Kennedy

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaDiAg

- Name: Vasodilator Agents

### Intervention Browse Module - Browse Leaves

- ID: M17388

- Name: Vancomycin

- Relevance: LOW

- As Found: Unknown

- ID: M8951

- Name: Gentamicins

- Relevance: LOW

- As Found: Unknown

- ID: M21783

- Name: Polymethyl Methacrylate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
