A Multi-center, Single-arm, Historically Controlled Pivotal Trial, to Assess the Safety and Effectiveness of Genex G as Part of the Surgical Treatment of Osteomyelitis of the Extremities.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 4
- 主要终点
- No further requirement for antibiotic treatment due to persisting symptoms of infection at the index site (i.e., additional antibiotics prescribed following completion of the initial systemic antibiotics prescribed post surgery.
研究概览
简要总结
The purpose of this trial is to determine if genex with gentamicin (genex G) an antibiotic loaded bone void filler, works to treat and is a safe option as part of the surgical treatment of osteomyelitis in the extremities.
详细描述
This trial is a multi-center, single arm, historically controlled, pivotal device study.
All participants diagnosed with osteomyelitis of the extremities (Cierny-Mader Classification grades I-IV) can be considered. All participants will undergo surgical debridement and will receive genex with gentamicin (genex G) antibiotic loaded bone void filler as part of the surgical treatment of osteomyelitis of the extremities. Participants will receive antibiotics per site specific requirements as clinically indicated. All participants will be followed up for 24 Months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with osteomyelitis of the extremities, who have failed antibiotic therapy and are requiring surgical intervention (unresolved osteomyelitis), Cierny-Mader classification of osteomyelitis grades I-IV. Patients presenting with Cierny-Mader grades I-II will be required to have a defect created as part of debridement surgery
- •Patients at least 18 years of age *1
- •Patient willing and able to provide written informed consent
- •Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator
- •Ability to achieve adequate surgical soft tissue coverage of the wound (primary tissue closure or surgical reconstruction including local and free soft tissue transfer)
- •1 Patients between 18 and 22 years of age require confirmation of skeletal maturity as validated by radiographs of the bone to be treated.
排除标准
- •Patients diagnosed with acute osteomyelitis
- •Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery
- •Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/dL (309umol/L) or being treated with dialysis
- •Participants with a terminal or palliative diagnosis (e.g. terminal cancer diagnosis) deemed to have less than 1 year life expectancy by their health care team
- •Uncontrolled diabetes mellitus (hemoglobin A1c levels >10%)
- •Pre-existing calcium metabolism disorder
- •Women who are pregnant or breastfeeding or planning on becoming pregnant during the study (a pregnancy test will be done in women of childbearing potential at screening and on the day of surgery)
- •History of hypersensitivity or contraindication to the investigational device or any of its ingredients (calcium phosphate, β-tricalcium phosphate, and aminoglycoside antibiotics)
- •Participation in an investigational drug/device study (within the last 60 days) or prior enrolment to the ADOPT GG study
- •Clinically significant or unstable medical or surgical condition that in the investigators opinion may preclude safe and complete study participation (for example patients medically unfit for surgery, general anesthesia, or any risk of significant blood loss resulting in significant risk to loss of life)
- •Current untreated malignant neoplasm(s), or current treatment with radiation therapy or chemotherapy
- •Current or recent history (within last 2 years) of active substance abuse (e.g. recreational drugs, narcotics, or alcohol) that meets DSM-5 severe criteria
- •Current user of any products containing nicotine
- •Currently incarcerated
研究组 & 干预措施
Single Arm
Participants will receive genex with Gentamicin, an antibiotic loaded bone void filler that supports bone healing, as part of the surgical treatment of osteomyelitis of the extremities.
干预措施: genex with gentamicin (genex G) (Device)
结局指标
主要结局
No further requirement for antibiotic treatment due to persisting symptoms of infection at the index site (i.e., additional antibiotics prescribed following completion of the initial systemic antibiotics prescribed post surgery.
时间窗: Month 12
Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 12.
No further surgical interventions required due to infection at the index site.
时间窗: Month 12
Need for further surgical interventions required due to infection at the index site will be assessed at Month 12.
No recurrence of sinus formation at the index site.
时间窗: Month 12
Recurrence of sinus formation at the index site will be assessed by a non-contrast CT scan at week 2 \& Month 12. Clinical endpoint assessments will also be used to measure this at post operative follow-up visits and will be assessed at Month 12.
次要结局
- No additional requirement for antibiotic treatment due to persisting symptoms of infection at the treatment site, i.e., additional antibiotics prescribed following completion of the initial systemic antibiotics prescribed post-surgery.(Month 24)
- No radiographic evidence of post op fractures.(Month 24)
- Radiographic evidence of new bone healing.(Month 24)
- No recurrence of sinus formation at the treatment site.(Month 24)
- No secondary surgical interventions (SSI's) related to the investigational treatment.(Month 24)
- No serious adverse events that are definitely related to genex G.(Month 24)
- Radiographic Evidence of new bone formation and product reabsorption.(Month 24)
- Infection resolution evaluated by radiographic assessment and clinical endpoints.(Month 24)
- Adverse events including wound problems, reaction to combination product, fracture at treatment site.(Month 24)
- Secondary Surgical Interventions (SSI's)(Month 24)
- Number of participants discontinuing therapy prematurely due to a device related event.(Month 24)
- Number of hospitalisations/re-hospitalisation due to treatment site Osteomyelitis.(Month 24)
- Quality of Life EQ-5D-5L(Month 24)