Clinical trial NCT05361941: Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
Official title: Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periprosthetic Joint Infections
Lead sponsor: Elute, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 204
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events.
timeFrame: 24 months after stage 1 surgery
measure: Absence of serious device related adverse events requiring re- operation
timeFrame: 24 months after stage 1 surgery
Secondary outcomes:
measure: Secondary outcome: patient reported quality of life.
timeFrame: 12 months after stage 1 surgery
measure: Secondary outcome: AKSS Score
timeFrame: 12 months after stage 1 surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Skokie
country: United States
facility: Endeavor Health Skokie Hospital
state: Illinois
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Womens Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: U Michigan Medical Center
state: Michigan
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Fargo
country: United States
facility: Sanford South University Medical Center
state: North Dakota
city: Columbus
country: United States
facility: JIS Orthopedics
state: Ohio
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: West Jordan
country: United States
facility: Jordan Valley Medical Center
state: Utah
city: Morgantown
country: United States
facility: West Virginia University Medical Center
state: West Virginia
Study officials:
affiliation: Holy Cross Jordan Valley Hospital
name: Bruce Evans, MD
role: STUDY_CHAIR
References: