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

Description

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).

Conditions

Periprosthetic Joint Infections

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Periprosthetic Joint Infections
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Skokie

Endeavor Health Skokie Hospital, Skokie, Illinois, United States, 60076

Indianapolis

OrthoIndy, Indianapolis, Indiana, United States, 46278

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Brigham & Womens Hospital, Boston, Massachusetts, United States, 02115

Ann Arbor

U Michigan Medical Center, Ann Arbor, Michigan, United States, 48109

New York

Hospital for Special Surgery, New York, New York, United States, 10021

Fargo

Sanford South University Medical Center, Fargo, North Dakota, United States, 58103

Columbus

JIS Orthopedics, Columbus, Ohio, United States, 43054

San Antonio

UT Health San Antonio, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Elute, Inc.,

Bruce Evans, MD, STUDY_CHAIR, Holy Cross Jordan Valley Hospital

Study Record Dates

2025-12-31