Using antibiotic-eluting grafts to promote bone growth in infected joint areas
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
This study is testing if a special antibiotic-coated graft can help people with infected joint areas grow new bone and lower the chances of infections after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Elute, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Trial ID | NCT05361941 on ClinicalTrials.gov |
What this trial studies
This pivotal, multi-center, randomized trial aims to evaluate the effectiveness of EP Granules with Tobramycin in promoting new bone growth and reducing recurrent infections in patients undergoing staged revisions for periprosthetic joint infections (PJIs). Participants will be divided into two groups: one receiving the investigational device and the other receiving standard-of-care treatment. The study is designed to be patient and assessor-blinded to ensure unbiased results. The primary outcomes will focus on the extent of new bone growth and the rate of infection recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with known infected total knee arthroplasties (TKAs) who can comply with follow-up requirements.
Not a fit: Patients with severe renal impairment, known hypersensitivity to aminoglycoside antibiotics, or uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing and reduce the risk of recurrent infections in patients with PJIs.
How similar studies have performed: While the use of antibiotic-eluting grafts is a promising approach, this specific methodology is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 11 other locations
- University of Southern California — Los Angeles, California, United States (Recruiting)
- Endeavor Health Skokie Hospital — Skokie, Illinois, United States (Recruiting)
- OrthoIndy — Indianapolis, Indiana, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Brigham & Womens Hospital — Boston, Massachusetts, United States (Recruiting)
- U Michigan Medical Center — Ann Arbor, Michigan, United States (Recruiting)
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
- Sanford South University Medical Center — Fargo, North Dakota, United States (Recruiting)
- JIS Orthopedics — Columbus, Ohio, United States (Recruiting)
- UT Health San Antonio — San Antonio, Texas, United States (Recruiting)
- Jordan Valley Medical Center — West Jordan, Utah, United States (Recruiting)
- West Virginia University Medical Center — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Ashok Khandkar, PhD
- Email: ak@elutinc.com
- Phone: 801-410-4330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.