A Retro-prospective Follow-up Study of the Safety and Performance of the Round XTENDOBUTTON™ Fixation Device Post Knee Repair in Australian Centres
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Success of the Round XTENDOBUTTON™ Fixation
研究概览
简要总结
The 12 month post-operative study is designed to provide safety and performance data on the Round XTENDOBUTTON™ fixation device after knee repair.
详细描述
This is a retro-prospective 12 month follow-up study of the safety and performance of the Round XTENDOBUTTON™ fixation device post knee repair in Australian centres.
The Primary Objective is to assess successful fixation with the Round XTENDOBUTTON™ and the Secondary Objective is to generate safety and performance evidence for the Round XTENDOBUTTON™ Device via the collection of functional outcomes, patient reported outcomes and safety data.
Forty subjects will be enrolled; who have had the round XTENDOBUTTON™ Device implanted. To eliminate the potential for selection bias, Investigators will consecutively screen all subjects who have undergone knee/ligament repair/reconstruction using the Round XTENDOBUTTON™ Fixation Device. Subjects meeting the eligibility criteria will be contacted regarding interest in study participation. Screening will be conducted in sequential order based on the date of subjects' knee repair procedure; earliest to latest. Screening efforts must be documented on a screening and enrollment log, on which reasons for exclusion from or denial to participate should be noted A medical chart review will be conducted to identify potential study subjects who have been implanted with the ROUND XTENDOBUTTON™ device at the study site.
- If a patient is eligible and would like to participate in the study, obtain written informed consent from the subject.----- Do not proceed until consent has been obtained -----
- Assign the subject a Subject ID number and instruct the subject on treatment procedures
- Complete Screening and Enrollment Log
- Obtain demographic information and medical history, including information on all relevant concomitant medications
- Collect operative information and implant disposition (including review of evidence of implant failure). If a failure has occurred, record details of the cause of failure. Collect x-rays if available.
- Complete Patient Questionnaires:
- Lysholm Score
- Tegner Activity Scale
- KOOS(Knee Injury and Osteoarthritis Outcome Score) Knee Score
- If any adverse events, adverse device effects or device deficiencies are observed or reported, they must be recorded
- Instruct the subject on follow-up procedures, including returning for Visit 2 in 6 months (-14 Days/+31 Days)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject received the Round XTENDOBUTTON™ for knee repair, 6 months (-14 Days/+31 Days) prior to enrollment
- •Subject agrees to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form
- •Subject is ≥ 18 years of age or ≤ 60 years of age at the time of surgery.
排除标准
- •Subject is entered in another investigational drug, biologic, or device study
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study
结局指标
主要结局
Success of the Round XTENDOBUTTON™ Fixation
时间窗: 6 months
The fixation success at 6 months post knee operation with the XTENDOBUTTON™ device. The Kaplan-Meier product limit survival estimates will be presented up to 6 months post-op along with the associated 95% confidence intervals. The event of interest will be fixation failure, defined as a revision due to a device failure, by 6 months.
次要结局
- Adverse events for the study duration(12 months)
- Fixation success of the Round XTENDOBUTTON™ at 12 months post operation(12 months)
- Lysholm Score(6 and 12 months)
- Tegner Activity Scale(6 & 12 months)
- KOOS Score (Knee Injury and Osteoarthritis Outcome Score)(6 & 12 months)
- Radiographic evaluation at 6 months(6 months)
- Radiographic evaluation at 12 months(12 months)