Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities (MAGIC)

January 7, 2025 updated by: Elute, Inc.
This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study with two arms: a treatment arm (where subjects will be treated with the EP Granules with Tobramycin investigational device in the 1st stage of a staged revision for periprosthetic joint infection (PJIs), and a control arm (where subjects are treated with the standard-of-care revision for infected PJIs).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study to demonstrate superiority of new bone growth and a reduction in recurring infections, and thereby improve outcomes for patients undergoing a staged revision for periprosthetic joint infections (PJIs).

The standard of care for treatment of PJIs typically involves either a 2-stage revision or 1.5 stage revision which entails loss of bone stock resulting from debridement of infected bone in Stage 1. In the Stage 2 procedure, surgeons use metal cones to make up for this bone loss and better support the revision implant. Inadequate bone growth could result in gaps at the the voids below the level of the cortical bone, resulting in regions with no contact with the revision implant or cement mantle. Such gaps could result in dead-space regions, and zones without new bone growth required to support the revision implant. Both deficiencies affect long-term survival of the revision implant.

The study has two arms: a treatment arm (where subjects will be treated with the EP Granules with Tobramycin investigational device in the 1st stage of the staged surgical treatment, and a control arm where subjects are treated with the standard-of-care staged surgical treatment for infected PJIs.

Outcomes are demonstration of new bone growth and reduction of recurrent infections.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ashok Khandkar, PhD
  • Phone Number: 801-410-4330
  • Email: ak@elutinc.com

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
        • Contact:
        • Contact:
          • Jay Lieberman, MD
        • Contact:
          • Daniel Oakes, MD
        • Contact:
          • Donald Longjohn, MD
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Recruiting
        • Endeavor Health Skokie Hospital
        • Contact:
        • Contact:
          • Hristo Piponov, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46278
        • Recruiting
        • OrthoIndy
        • Contact:
        • Contact:
          • Christopher Pomeroy, MD
        • Contact:
          • Greg Dikos, MD
        • Contact:
          • Michael Cross, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • U Michigan Medical Center
        • Contact:
        • Contact:
          • Michael Kheir, MD
        • Contact:
          • Christopher Carender, MD
        • Contact:
          • Elizabeth Klag, MD
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
        • Contact:
          • Alberto Carli, MD
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Sanford South University Medical Center
        • Contact:
        • Contact:
          • Todd Sekundiak, MD
    • Ohio
      • Columbus, Ohio, United States, 43054
        • Recruiting
        • JIS Orthopedics
        • Contact:
        • Contact:
          • David Crawford, MD
        • Contact:
          • Zackary Byrd, MD
        • Contact:
          • Adolph Lombardi, MD
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health San Antonio
        • Contact:
        • Contact:
          • Frank Buttacavoli, MD
        • Contact:
          • Chance Moore, MD
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Jordan Valley Medical Center
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Medical Center
        • Contact:
        • Contact:
          • Adam Klein, MD
        • Contact:
          • Matthew Dietz, MD
        • Contact:
          • Benjamin Frye, MD
        • Contact:
          • Timothy Murphy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages and sexes eligible: at least 22 years, male and female
  • Candidates with known infected TKA
  • Life expectancy of at least 1 year
  • Patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen
  • Adequate soft tissue coverage
  • Signed institutional review board approved informed consent

Exclusion Criteria:

  • Severe renal impairment with eGFR <50 ml/min/1.73 m2, or being treated with dialysis

    • Known hypersensitivity to aminoglycoside antibiotics, or calcium hydroxyapatite
    • Pre-existing calcium metabolism disorder
    • Uncontrolled diabetes mellitus (hemoglobin A1c levels > 8)
    • A current endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hyperthyroid parathyroid hormone disorder, Ehler- Danlos syndrome, osteogenesis imperfecta)
    • Neuromuscular disorders such as myasthenia gravis
    • Untreated malignant neoplasm(s), or currently undergoing radiation chemotherapy
    • Inadequate neurovascular status in the involved limb that may jeopardize healing
    • HIV
    • Pregnancy
    • Adult patients requiring a legal guardian to sign informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
The device will be placed in voids at Stage 1. This will be followed by IV therapy for about six weeks, followed by assessment of infection, with a stage 2 surgery to follow. (For 1.5-stage, stage 2 procedure is optional). During the stage 2 surgery, the surgeon completes the procedure with affixing the revision implants.
Device: EP Granules with Tobramycin
EP Granules with Tobramycin is a Ca-salt resorbable intended for orthopedic applications as a bone void filler for bone gaps or voids and in cases where risk of post-operative infection is high, such as the first stage of a 2-stage or 1.5 stage revision of an infected total joint.
Active Comparator: Control Arm
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. For 1.5-stage procedures, the stage 2 procedure is optional.
Device: empty voids
Voids are left empty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events.
Time Frame: 24 months after stage 1 surgery
A] New bone growth observed in voids at 12 months versus pre-op stage 1 and B] Absence of infection at 24 months versus pre-op stage 1 surgery.
24 months after stage 1 surgery
Absence of serious device related adverse events requiring re- operation
Time Frame: 24 months after stage 1 surgery

A serious device related adverse event requiring re-operation

  • Success = no adverse event occurs
  • Failure = adverse event occurs
24 months after stage 1 surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome: patient reported quality of life.
Time Frame: 12 months after stage 1 surgery
SF-12 or PROMIS -10 score
12 months after stage 1 surgery
Secondary outcome: AKSS Score
Time Frame: 12 months after stage 1 surgery
1. AKSS Pain and Function Scores
12 months after stage 1 surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elute, Inc.

Investigators

  • Study Chair: Bruce Evans, MD, Holy Cross Jordan Valley Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-001-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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