A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Successful Treatment of Infection Based on Lab Values and Culture
研究概览
简要总结
This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be ≥ 21 years of age
- •Have an ankle-related infection
- •Is skeletally mature, as evidenced by closed epiphyses.
- •Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
- •Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
- •If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant until study completion.
排除标准
- •Infections that do not involve the ankle
- •Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
- •Affected limb is dysvascular
- •Where adequate soft-tissue coverage cannot be achieved
- •Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
- •Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
- •Are currently a prisoner
- •Have any medical condition or other circumstances, in the judgment of the Investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities.
- •History of vancomycin or gentamicin allergy
- •Are implanted with other antibiotic eluting products.
研究组 & 干预措施
Subjects with REMEDY Spectrum IM Spacer Nail
This is the REMEDY Spectrum IM Spacer Nail treatment group.
干预措施: REMEDY Spectrum IM Spacer Nail (Combination Product)
结局指标
主要结局
Successful Treatment of Infection Based on Lab Values and Culture
时间窗: 6 months
Healed wound and no infection recurrence caused by the same organism strain infection for duration of two weeks post antibiotic regimen.
次要结局
未报告次要终点