Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities

Not Applicable

Recruiting

• Conditions: Periprosthetic Joint Infections

• 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.

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-05
• Study Start: 2023-08-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

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