Single-center PMCF - Study on the Performance and Safety of MonoPlus® in Patients Undergoing Orthopedic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Aesculap AG
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Rate of maintained soft tissue approximation
研究概览
简要总结
Single-center postmarket clinical follow-up study (PMCF) on the performance and safety of MonoPlus® in patients undergoing orthopedic surgery
详细描述
This post-market clinical follow-up (PMCF) study on the use of MonoPlus®, a polydioxanone absorbable suture material, will expand the information available on the performance and safety of MonoPlus® used for orthopedic surgeries conducted in daily practice conditions.
The study is designed as a prospective, non-interventional, single-center, PMCF cohort study. The product under investigation will be used in routine clinical practice and according to the Instructions for Use. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied, and all study visits will coincide with those that will be scheduled for routine follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female patients
- •Need for orthopedic surgery
- •Use of MonoPlus® for the orthopedic surgery in the routine clinical practice
- •Written informed consent form.
排除标准
- •Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures
- •Prosthetic surgery secondary to infection
- •Radiation to the surgical area
- •Participation or planned participation in any clinical trial before study follow-up is completed
- •Previous tendon/ligament repair intervention
- •Pregnancy
- •Patients with hypersensitivity or allergy to the suture material
- •Patients taking medical consumption that might affect wound healing.
结局指标
主要结局
Rate of maintained soft tissue approximation
时间窗: 3 months post-surgery
For the assessment of MonoPlus® effectiveness the percentage of patients that maintain soft tissue approximation integrity examined by ultrasound is evaluated
次要结局
- Changes in strength(at baseline, 6 weeks and 3 months post-surgery.)
- Incidence of reoperations(Up to last follow up 12 months post operatively)
- Changes in functional performance for Patients undergoing upper extremity surgery(preoperatively, 6 weeks and 3 months post-surgery)
- Changes in functional performance for Patients undergoing Knee surgery(preoperatively, 6 weeks and 3 months post-surgery)
- The incidence of wound infections during the study follow-up.(12-month study follow-up.)
- Development of Pain measured with Visual Analogue Scale (VAS)(Preoperatively, hospital discharge (approximately 10 days postoperatively), 6 weeks, 3 months and 12 months after surgery)
- Changes in functional performance for Patients undergoing Hip surgery(preoperatively, 6 weeks and 3 months post-surgery)
- The length of hospital stay after the orthopedic surgery.(up to hospital discharge (approximately 10 days postoperatively))
- Assessment of intraoperative handling of suture material(intraoperatively)
- The incidence of post-surgery complicated wound healing.(12-month study follow-up.)
- Rate of Adverse Device Effects(up to last follow-up at 12 months postoperatively)