RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-08-31
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05361941

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages and sexes eligible: at least 22 years, male and female
  2. * Candidates with known infected TKA
  3. * Life expectancy of at least 1 year
  4. * 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
  5. * Adequate soft tissue coverage
  6. * Signed institutional review board approved informed consent
  1. * Severe renal impairment with eGFR \<50 ml/min/1.73 m2, or being treated with dialysis
  2. * Known hypersensitivity to aminoglycoside antibiotics, or calcium hydroxyapatite
  3. * Pre-existing calcium metabolism disorder
  4. * Uncontrolled diabetes mellitus (hemoglobin A1c levels \> 8)
  5. * 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)
  6. * Neuromuscular disorders such as myasthenia gravis
  7. * Untreated malignant neoplasm(s), or currently undergoing radiation chemotherapy
  8. * Inadequate neurovascular status in the involved limb that may jeopardize healing
  9. * HIV
  10. * Pregnancy
  11. * Adult patients requiring a legal guardian to sign informed consent form

Contacts and Locations

Study Contact

Ashok Khandkar, PhD
CONTACT
801-410-4330
ak@elutinc.com
Eva Serio, BS
CONTACT
801-410-4330
eva@elutinc.com

Principal Investigator

Bruce Evans, MD
STUDY_CHAIR
Holy Cross Jordan Valley Hospital

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States
Endeavor Health Skokie Hospital
Skokie, Illinois, 60076
United States
OrthoIndy
Indianapolis, Indiana, 46278
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham & Womens Hospital
Boston, Massachusetts, 02115
United States
U Michigan Medical Center
Ann Arbor, Michigan, 48109
United States
Hospital for Special Surgery
New York, New York, 10021
United States
Sanford South University Medical Center
Fargo, North Dakota, 58103
United States
JIS Orthopedics
Columbus, Ohio, 43054
United States
UT Health San Antonio
San Antonio, Texas, 78229
United States
Jordan Valley Medical Center
West Jordan, Utah, 84088
United States
West Virginia University Medical Center
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Elute, Inc.

  • Bruce Evans, MD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2023-08-31
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-08-31
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Periprosthetic Joint Infections