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Antibiotic Eluting Graft

Antibiotic Eluting Graft for Joint Infections (MAGIC Trial)

N/A

Recruiting

Research Sponsored by Elute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages eligible: at least 22 years, male and female

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after stage 2 surgery

Awards & highlights

MAGIC Trial Summary

This trial will compare a new two-stage treatment for infected joint replacements to the current standard of care.

Who is the study for?

Adults at least 22 years old with infected artificial joints (PJI) and bone voids visible on X-rays can join. They must be able to follow the study plan, live in a stable location, and have a life expectancy of over a year. People with severe kidney issues, allergies to certain antibiotics or materials used in the graft, uncontrolled diabetes, metabolic disorders affecting bone growth, neuromuscular conditions, untreated cancer or those undergoing cancer treatment are excluded.Check my eligibility

What is being tested?

The trial is testing EP Granules with Tobramycin as part of a two-stage surgery for joint infections against standard surgical care. Participants are randomly assigned to either receive this new treatment or undergo regular care without knowing which group they're in.See study design

What are the potential side effects?

Potential side effects may include reactions related to Tobramycin such as hearing problems or kidney issues; however specific side effects will depend on individual patient responses and their overall health condition.

MAGIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 22 years old or older.

MAGIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months after stage 2 surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months after stage 2 surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after stage 2 surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Re-Irradiation

New bone growth

Reduction in recurring infection rate.

Secondary outcome measures

: AKSS Score

: number of metal augments

: patient reported quality of life.

MAGIC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

The device will be placed in voids at Stage 1. This will be followed by IV therapy for a minimum of six weeks, followed by a pathology assessment of infection by needle aspiration, after week 8, with a stage 2 surgery scheduled after week 9. During the stage 2 surgery, the surgeon makes a qualitative assessment of new bone, and completes the procedure with affixing the revision implants. If the surgeon observes a depression in the surface layer resulting from subsidence due to partial resorption of the device, the surgeon may fill such gaps with additional granules of the device. An intraoperative set of radiographic images are taken during the stage 2 surgery.

Group II: Control ArmActive Control1 Intervention

In the standard of care arm, voids are left empty and a bone cement spacer placed during stage 1 surgery. This is followed by IV therapy for a minimum of six weeks, followed by a pathology assessment of infection by needle aspiration, after week 8, with a stage 2 surgery scheduled after week 9. During the stage 2 surgery, the spacer is removed and procedure completed by affixing the revision implants.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Elute, Inc.Lead Sponsor

Bruce Evans, MDStudy ChairJordan Valley Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous medical facilities in the United States conducting this research?

"This study is presently looking for participants at 8 sites, including but not limited to Los Angeles, Indianapolis and Boston. To reduce travel needs, it is advised that one selects the closest trial site when applying."

Answered by AI

Are there any vacancies available in this research endeavor?

"According to the details listed on clinicaltrials.gov, this investigation is presently search for participants as of September 6th 2022 and was last modified on the same date."

Answered by AI

How many individuals have currently enrolled in this research effort?

"Affirmative. As per the evidence stored on clinicaltrials.gov, this medical research is presently searching for individuals to take part in their study. This trial was first posted on September 6th 2022 and has since been updated with changes applied as of that same date. 132 people need to be enrolled across 8 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities

2023. "Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05361941.