Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 59
- 试验地点
- 9
- 主要终点
- Kujala Score
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 reconstruction of a ligament in the kneecap - the Medial Patellofemoral Ligament (MPFL).
The Medical Devices in this study, 10mm Poly-Tape and 5mm Infinity-Lock Tape, are Class III CE-Marked devices manufactured by Xiros Ltd. Both devices fall under the Poly-Tape family. Poly-Tapes are single-use devices, they are indicated for patients requiring soft tissue approximation and reconstruction of ligaments and tendons. The device can be fixed to the bone using several different methods, including screws.
This study is a prospective, multicentre, consecutively recruited non-randomised study. The total length of the study is expected to be 7 years. This includes a recruitment period of approximately 24 months and a 5-year follow-up. A total of 59 subjects will be enrolled into the study with follow up at 6 weeks, 6 months, 1 year, 2 years and 5 years in clinic and by questionnaires. All subjects treated with either the 10mm Poly-Tape or 5mm Infinity-Lock Tape for MPFL reconstruction, 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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 13 years old or above. Patients who require MPFL reconstruction. Patients 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
- •These devices should not be used in procedures which bridge, disturb, or disrupt the growth plate in immature patients since they will not elongate as the patient grows.
- •Patients known to be hypersensitive to titanium alloy or polyester. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation.
- •Patients with any infections or structural or pathological condition of the bone or soft tissue that would be expected to impair healing or secure fixation. Bone quality should be assessed prior to surgery.
- •Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.
- •Patients for whom the implantation is intended to be non-permanent, since they integrate well with the patient's tissue.
研究组 & 干预措施
Poly-Tape Devices
Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction
干预措施: Poly-Tape Devices (Device)
结局指标
主要结局
Kujala Score
时间窗: 1 year
The primary performance objective is to determine the effect of MPFL reconstruction on symptoms and functional limitations 1 year after surgery, measured using the Kujala .Total score. Total scores range from 0 to 100 with high scores indicating good
Redislocation/subluxation events
时间窗: 1 year
The primary safety objective is to assess redislocation/subluxation events at 1 year after surgery
次要结局
- Patient-reported quality of life (RANDShort form 36)(5 years)
- Full range of motion (ROM)(5 years)
- Norwich Patellar Instability (NPI) score(5 years)
- Patient satisfaction with Surgery(5 years)
- Patient-reported activity levels(5 years)
- Adverse events, including re-dislocation/subluxation(5 years)