Status:
RECRUITING
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
Lead Sponsor:
Elute, Inc.
Conditions:
Periprosthetic Joint Infections
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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 wit...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT05361941
Start Date
August 31 2023
End Date
December 31 2025
Last Update
January 8 2025
Active Locations (12)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Endeavor Health Skokie Hospital
Skokie, Illinois, United States, 60076
3
OrthoIndy
Indianapolis, Indiana, United States, 46278
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114