Post-market Clinical Follow-up (PMCF) Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Achilles Tendon Rupture Score (ATRS)
研究概览
简要总结
This is a Post Market Clinical Follow Up Study in Orthopaedics, it will verify the long-term safety and performance of the device in the intended patient population, when indicated for the acute repair of the Achilles tendon.
The Medical Device in this study AchilloCordPLUS is a Class IIb UKCA-Marked device manufactured by Xiros Ltd.
详细描述
This is a Post Market Clinical Follow Up Study in Orthopaedics, it will verify the long-term safety and performance of the device in the intended patient population, when indicated for the acute repair of the Achilles tendon.
The Medical Device in this study AchilloCordPLUS is a Class IIb UKCA-Marked device manufactured by Xiros Ltd.
AchilloCordPLUS is a single-use device, indicated for patients with acute Achilles tendon ruptures. It is particularly suited to active patients where an extended period of postoperative immobilisation is undesirable.
This study is a prospective, single-centre, consecutively recruited non-randomised study. The total length of the study is expected to be 3 years. This includes a recruitment period of approximately 12 months and a 2-year follow-up.
This study has now closed to follow-up, with a recruitment of 19 participants. Follow up is at 2,4,6,8 and 12 weeks, 6 months and 1 and 2 years. All subjects treated with the AchilloCordPLUS for acute Achilles tendon repair will be consecutively recruited into the study.
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
- •Patients must be skeletally mature and be 18 years old or above.
- •Patients requiring end to end repair for acute Achilles tendon rupture.
- •Patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and has provided written informed consent as approved by the Research Ethics Committee (REC).
排除标准
- •Patients with chronic ruptures of the Achilles tendon.
- •Patients with bilateral ruptures.
- •Patients with known hypersensitivity to implant materials. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation.
- •Patients with infections or any structural or pathological condition of the bone or soft tissue that would be expected to impair healing or prevent secure fixation.
- •Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.
研究组 & 干预措施
AchilloCordPLUS
End to end repair for acute Achilles tendon rupture with AchilloCordPLUS
干预措施: AchilloCordPLUS™ System Implant (Device)
结局指标
主要结局
Achilles Tendon Rupture Score (ATRS)
时间窗: 6 months
Change in ATRS Score 0-100 0=major limitations 100=no limitations
adverse events (AE)
时间窗: 6 months
Number of adverse events (AE) at 6 months after surgery which directly relate to the procedure that may have an effect on the patient's outcome (for example, irritation at the surgery site, re-rupture, deep-vein thrombosis (DVT), wound infection and sural nerve damage).
次要结局
- Achilles Tendon Rupture Score (ATRS)(2 years)
- Length of time to unaided full weight bearing(2 years)
- return to work and return to sport.(2 years)
- Tegner Activity Scale (pre-injury)(2 years)
- RAND Short Form 36 (SF 36) V1(2 years)
- Tegner Activity Scale (baseline)(2 years)
- Range of Motion(6 months)
- Calf Circumference(6 months)
- Adverse Event(2 years)