Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities (MAGIC)

Elute, Inc.

Status: Enrolling

Conditions: Periprosthetic Joint Infections

Treatments: Device: EP Granules with Tobramycin; Device: empty voids

Study type: Interventional

Funder types: Industry

Identifiers

NCT05361941

TP-001-21

Details and patient eligibility

About

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 2-stage surgical treatment for periprosthetic joint infection (PJIs), and a control arm (where subjects are treated with the standard-of-care 2-stage surgical treatment for infected PJIs).

Full 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 2-stage surgical revision treatment for periprosthetic joint infections (PJIs).

The standard of care for treatment of PJIs typically involves a 2-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 2-stage surgical treatment, and a control arm where subjects are treated with the standard-of-care 2-stage surgical treatment for infected PJIs.

Outcomes are demonstration of new bone growth and reduction of recurrent infections.

Enrollment: 132 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages and sexes eligible: at least 22 years, male and female
• Candidates with known infected TKA, according to MSIS standard: getting an erythrocyte sedimentation rate and C-reactive protein followed by selective aspiration of the joint if these values are elevated or if the clinical suspicion is high. Synovial fluid obtained should be sent for a synovial fluid white blood cell count, differential, and cultures.
• Radiographs demonstrating bone voids on the preoperative X-ray in patients with known Prosthetic Joint Infection (PJI)
• 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

• Renal failure or documented chronic kidney disease with creatinine ≥3.5 mg/L or being treated with dialysis

  • Known hypersensitivity to aminoglycoside antibiotics, calcium sulfa 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
  • Previous history of osteomyelitis in the index limb
  • HIV
  • Pregnancy
  • Adult patients requiring a legal guardian to sign informed consent form

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

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.

Treatment:

Device: EP Granules with Tobramycin

Control Arm

Active Comparator group

Description:

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:

Device: empty voids