Retrospective Clinical Study for the Evaluation of the Safety and Clinical Performance of the Medical Device "Guided Growth Plate System Plus" (GGPSP) for the Treatment of Bone Deformities of the Lower Limbs in Skeletally Not Mature Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Safety Measurement: Percentage of Subjects Who During the Observation Period Have at Least One Complication Certainly or Potentially Related to the Device in the Studio
研究概览
简要总结
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided Growth Plate System (GGPS) from which it differs for small modifications compared to the original design. The purpose of the study is to collect clinical evidence from the use of the device in a representative number of pediatric patients who have already been treated with the device in the study and with at least one control visit post removal of plaque..
For this purpose, a retrospective PMCF study was considered to be the most appropriate study design to obtain the necessary information.
详细描述
Guided Growth Plate System Plus (also named 8 Plate Plus) has been developed to redirect long bone growth and is used to correct gradually angular deformity in growing children. The device is indicated for the treatment of specific conditions/pathologies between which:
- deformity of the knee (femur and / or tibia) in varum/valgus or flexural extension;
- deformity of the ankle in varum/valgus or plantar flexion;
- femur and/or tibia length discrepancy.
Objectives:
The primary objective of the clinical investigation is to assess the safety of the 8 Plate Plus.
The secondary objective of the clinical investigation is to assess the clinical benefit of the 8 Plate Plus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •he/she has been diagnosed with an angular deformity or discrepancy in length of femur and/or tibia
- •at the time of treatment he/she had not yet reached the age of 18;
- •at the time of treatment the growth plates of the treated limbs was not already closed;
- •according to the Investigator's judgment, angular deformity and/or length discrepancy had a regular indication for surgical treatment with tensioning plates
- •deformity was treated with the 8 Plate Plus , according to the manufacturer's instructions
- •the treatment with 8 Plate Plus was completed and the patient had at least one post-removal control of the plate
- •clinical patient data for the evaluation of safety and benefit of the device are still available
排除标准
- •Not treated with 8 Plate Plus to correct upper limb deformities only and not lower limb deformities
- •its clinical data are no longer accessible and /or do not allow the evaluation of the safety and benefit of the device under study
- •had a medical condition which constitutes a contraindication to treatment with 8 Plate Plus in accordance with the manufacturer's instructions for use;
- •at the same time was treated with an unauthorised device which could not be removed without putting the patient's safety at risk.
结局指标
主要结局
Safety Measurement: Percentage of Subjects Who During the Observation Period Have at Least One Complication Certainly or Potentially Related to the Device in the Studio
时间窗: an average of 2 years
Such complications shall be understood as: * a serious adverse event expected or not expected * a hardware failure (for example, breaking, detaching or folding of the plate or screws).
次要结局
- Efficacy Measurement: the Percentage of Subjects That During the Observation Period Have Achieved the Treatment Objectives(an average of 2 years)