Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
- Conditions
- Periprosthetic Joint Infections
- Interventions
- Device: empty voidsDevice: EP Granules with Tobramycin
- Registration Number
- NCT05361941
- Lead Sponsor
- Elute, Inc.
- 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 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).
- 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, and thereby improve outcomes for patients undergoing a staged revision for periprosthetic joint infections (PJIs).
The standard of care for treatment of PJIs typically involves either a 2-stage revision or 1.5 stage revision which entails loss of bone stock resulting from debridement of infected bone in Stage 1. In the Stage 2 procedure, surgeons use metal cones to make up for this bone loss and better support the revision implant. Inadequate bone growth could result in gaps at the the voids below the level of the cortical bone, resulting in regions with no contact with the revision implant or cement mantle. Such gaps could result in dead-space regions, and zones without new bone growth required to support the revision implant. Both deficiencies affect long-term survival of the revision implant.
The study has two arms: a treatment arm (where subjects will be treated with the EP Granules with Tobramycin investigational device in the 1st stage of the staged surgical treatment, and a control arm where subjects are treated with the standard-of-care staged surgical treatment for infected PJIs.
Outcomes are demonstration of new bone growth and reduction of recurrent infections.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 204
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm empty voids In the standard of care arm, voids are left empty and a bone cement spacer placed during stage 1 surgery. This is followed by IV therapy for a minimum of six weeks, followed by a pathology assessment of infection by needle aspiration, after week 8, with a stage 2 surgery scheduled after week 9. During the stage 2 surgery, the spacer is removed and procedure completed by affixing the revision implants. Treatment Arm EP Granules with Tobramycin The device will be placed in voids at Stage 1. This will be followed by IV therapy for a minimum of six weeks, followed by a pathology assessment of infection by needle aspiration, after week 8, with a stage 2 surgery scheduled after week 9. During the stage 2 surgery, the surgeon makes a qualitative assessment of new bone, and completes the procedure with affixing the revision implants. If the surgeon observes a depression in the surface layer resulting from subsidence due to partial resorption of the device, the surgeon may fill such gaps with additional granules of the device. An intraoperative set of radiographic images are taken during the stage 2 surgery.
- Primary Outcome Measures
Name Time Method A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events. 24 months after stage 1 surgery A\] New bone growth observed in voids at 12 months versus pre-op stage 1 and B\] Absence of infection at 24 months versus pre-op stage 1 surgery.
Absence of serious device related adverse events requiring re- operation 24 months after stage 1 surgery A serious device related adverse event requiring re-operation
* Success = no adverse event occurs
* Failure = adverse event occurs
- Secondary Outcome Measures
Name Time Method Secondary outcome: patient reported quality of life. 12 months after stage 1 surgery SF-12 or PROMIS -10 score
Secondary outcome: AKSS Score 12 months after stage 1 surgery 1. AKSS Pain and Function Scores
Trial Locations
- Locations (12)
Endeavor Health Skokie Hospital
🇺🇸Skokie, Illinois, United States
U Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Sanford South University Medical Center
🇺🇸Fargo, North Dakota, United States
UT Health San Antonio
🇺🇸San Antonio, Texas, United States
West Virginia University Medical Center
🇺🇸Morgantown, West Virginia, United States
University of Southern California
🇺🇸Los Angeles, California, United States
OrthoIndy
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham & Womens Hospital
🇺🇸Boston, Massachusetts, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
JIS Orthopedics
🇺🇸Columbus, Ohio, United States
Jordan Valley Medical Center
🇺🇸West Jordan, Utah, United States