Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock™ Button System for Acromioclavicular Joint Stabilisation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Device Related or Procedure Related Adverse events
研究概览
简要总结
This is a Post-market Clinical Follow-up Study. It will verify the long-term safety and performance of the Infinity-Lock Button System (ILBS) when used for acute and chronic dislocations of the Acromioclavicular Joint and used as described by the manufacturer's instructions.
详细描述
This is a Post-market Clinical Follow-up Study. It will verify the long-term safety and performance of the Infinity-Lock Button System (ILBS) when used for acute and chronic dislocations of the Acromioclavicular Joint and used as described by the manufacturer's instructions.
The medical device (ILBS) in this study is already on the market and is manufactured by Xiros Ltd.
The ILBS comprises of a polyester flexible tubular tape and a titanium button. The tape is used to secure the joint and the button is used to secure the tape into position.
This study will collect data on patients who meet the entry criteria and receive the device; it will recruit patients from several clinical sites.
All patients in the study will receive the ILBS, as it is a single armed study. The total length of the study is expected to be 4.5 years; this includes a recruitment period of approximately 18 months and a 3-year 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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 16 years old or above.
- •Patient is diagnosed with acute or chronic Grade Ill-VI ACJ dislocation.
- •Patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC).
排除标准
- •Known hypersensitivity to implant materials. If the patient is suspected of having any foreign body sensitivity, appropriate tests should be made prior to implantation.
- •Infections or any other structural or pathological condition of the bone or soft tissue (such as hyperlaxity) that would be expected to impair healing or secure fixation.
- •Patients unable or unwilling to restrict activities to prescribed levels or follow a rehabilitation programme during the healing period.
- •Skeletally immature patients are not suited as the Infinity-Lock™ Button System will not elongate with growth. The use of this medical device and placement of hardware or implants must not bridge, disturb or disrupt the growth plate.
- •Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.
研究组 & 干预措施
Infinity-Lock™ Button System
Participants diagnosed with acute or chronic Grade Ill-VI ACJ dislocation who require treatment with an Infinity-Lock Button System who meet the inclusion criteria and none of the exclusion criteria.
干预措施: Infinity-Lock Button System (Device)
结局指标
主要结局
Device Related or Procedure Related Adverse events
时间窗: 1 year
device-related and/or procedure-related adverse events up to 1 year after surgery.
Constant Murley Score (CMS)
时间窗: 1 year
The primary performance endpoint is the change in the CMS from baseline to 1 year after surgery. Minimum score is 0 maximum is 100 with the better functioning shoulders having a greater number of points.
次要结局
- Device-related and/or procedure-related adverse events(3 years)
- Constant Murley Score (CMS)(3 years)
- American Shoulder and Elbow Surgeons Score (ASES)(3 years)
- RAND Short Form 36 (SF-36) V1(3 years)
- Nottingham Clavicle Score (NCS)(3 years)
- Ability to perform normal daily work and normal recreational activities(3 years)
- coracoclavicular distance(1 year)