Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device : Evaluation of Quality of Life Scores, Angular Correction, Bone Consolidation and Occurrence of Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Novastep
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of patient's foot determined thanks to the "general sub-score" of the European Foot and Ankle Society scale
研究概览
简要总结
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.
The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation functional capacities of the patient's foot. It will be assessed with "general sub-score" of the EFAS questionnaire determined during the postoperative visit at 6 months.
The evaluation of quality of life scores, angular correction, bone consolidation and occurrence of adverse events will also be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patient with a hallux valgus foot pathology requiring correction
- •First line operation
- •Use of the medical device concerned PECA Bunion
- •Unilateral operation
- •Patient aged 18 or over
- •Isolated hallux valgus correction, without associated surgical procedures
- •Patient able to respect the prescriptions and recommendations of his surgeon
- •Patient able to read and understand the information note on the objectives of the study and the collection of their data
- •Patient able to sign a consent form
排除标准
- •Patient with a contraindication to the device under investigation,
- •Simultaneous participation in another clinical investigation protocol,
- •Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors.
结局指标
主要结局
Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of patient's foot determined thanks to the "general sub-score" of the European Foot and Ankle Society scale
时间窗: 6 months post-operative
Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of the patient's foot, with the evaluation of the "general sub-score" of the European Foot and Ankle Society (EFAS) questionnaire during post-operative visit at 6 months. The questionnaire collects information on the following categories: functional capacity of the patient's foot in general (6 items), and functional capacity of the patient's foot during sport (4 items). The scores to be calculated range from 0-4 per question, 0-24 for the general category (the only category to be evaluated for the primary outcome). A score of 0 indicates the worst possible foot/ankle symptoms and 24 indicates no symptoms foot/ankle. In this study, an objective score of 16 (out of a total of 24) was determined
次要结局
- Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of radiographics parameters (X-rays) with the evaluation of evolution of consolidation(6-8 weeks, 3-4 months, 6 months and 2 years post-operative)
- Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters with the evaluation of the evolution of the pain with Visual Analog Scale(6-8 weeks, 3-4 months, 6 months and 2 years post-operative)
- Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters thanks to the evaluation of mobility (dorsiflexion and plantar flexion)(6-8 weeks, 3-4 months, 6 months and 2 years post-operative)
- Confirm the safety of the device under investigation for the correction of hallux valgus by evaluating the occurrence of adverse events, complications and device defects(From inclusion visit (V0) to 2 years post-operative visit)
- Confirm performance and effectiveness of the device for the correction of hallux valgus with the evaluation of clinical parameters: evaluation of functionality of the foot in sport with "sub-score sport" of the European Foot and Ankle Society scale(3-4 months, 6 months and 2 years post-operative)
- Confirm performance and effectiveness of the device for the correction of hallux valgus with the evaluation of radiographics parameters: evaluation of evolution of angular measures (hallux valgus, Inter-metatarsal and Distal Metaphyseal Articular Angles)(6-8 weeks, 3-4 months, 6 months and 2 years post-operative)
- Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus with evaluation of clinical parameters: evaluation of the evolution of the quality of life with American Orthopedic Foot and Ankle Scale(3-4 months, 6 months and 2 years post-operative)
- Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters : evaluation of the evolution of the quality of life with The Short Form (36) Health Survey(6 months and 2 years post-operative)