Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Elute, Inc.
- 入组人数
- 204
- 试验地点
- 23
- 主要终点
- A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Pregnancy
- •Adult patients requiring a legal guardian to sign informed consent form
研究组 & 干预措施
Treatment Arm
The device will be placed in voids at Stage 1. This will be followed by IV therapy for about six weeks, followed by assessment of infection, with a stage 2 surgery to follow. (For 1.5-stage, stage 2 procedure is optional). During the stage 2 surgery, the surgeon completes the procedure with affixing the revision implants.
干预措施: EP Granules with Tobramycin (Device)
Control Arm
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. For 1.5-stage procedures, the stage 2 procedure is optional.
干预措施: empty voids (Device)
结局指标
主要结局
A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events.
时间窗: 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
时间窗: 24 months after stage 1 surgery
A serious device related adverse event requiring re-operation * Success = no adverse event occurs * Failure = adverse event occurs
次要结局
- Secondary outcome: AKSS Score(12 months after stage 1 surgery)
- Secondary outcome: patient reported quality of life.(12 months after stage 1 surgery)