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

Обзор

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 + Tobramycin (EP G + T) investigational device, a combination device + antibiotic, 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).

Подробное описание

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.

Вмешательства

• Устройство EP Granules with Tobramycin
  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.
• Устройство empty voids
  Voids are left empty

Первичные конечные точки

• A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events. [Срок оценки: 24 months after stage 1 surgery]
• Absence of serious device related adverse events requiring re- operation [Срок оценки: 24 months after stage 1 surgery]

Вторичные конечные точки (2)

• Secondary outcome: patient reported quality of life. [Срок оценки: 12 months after stage 1 surgery]
• Secondary outcome: AKSS Score [Срок оценки: 12 months after stage 1 surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 16 центров

• University of Southern California — Los Angeles
• Georgetown University Medical Center — Washington D.C.
• Endeavor Health Skokie Hospital — Skokie
• OrthoIndy — Indianapolis
• Sinai Hospital — Baltimore
• Massachusetts General Hospital — Boston
• Brigham & Womens Hospital — Boston
• U Michigan Medical Center — Ann Arbor
• … и ещё 8 центров

Идентификаторы

NCT: NCT05361941 · TP-001-21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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