Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
Elute, Inc.
204 participants
Aug 31, 2023
INTERVENTIONAL
Conditions
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 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).
Eligibility
Inclusion Criteria6
- 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 Criteria11
- 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
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Interventions
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.
Voids are left empty
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05361941