A Multicenter Randomized Controlled Trial to Investigate the Treatment Outcome of PHILOS Screw Augmentation Compared to PHILOS Without Augmentation in Older Adult Patients With Proximal Humerus Fractures
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
- 9
- 主要终点
- Any occurrence of radiographically confirmed mechanical failure during the first year after treatment.
研究概览
简要总结
The primary objective is to compare the mechanical failure risks in the first year after treatment.
详细描述
Biomechanical tests have shown that augmentation of screws or nails with polymethylmethacrylate (PMMA) leads to increased mechanical properties of the bone-implant complex, leading to the assumption that augmentation could reduce mechanical failures in patients. While a few clinical studies have already been performed with augmented trochanteric nails in proximal femur fractures, no clinical studies exist with the use of Proximal Humerus Internal Locking System (PHILOS) and (PMMA) augmentation for the treatment of fractures in the proximal humerus.
In this study a new standardized technique for augmentation of screw tips using high viscous PMMA cement (Traumacem V+) with the PHILOS plate will be applied. Fracture treatment with PHILOS Screw Augmentation will be compared with treatment with PHILOS without augmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Low energy trauma (e.g. fall from standing height)
- •Radiologically confirmed closed fracture (≤ 10 days) of the proximal humerus
- •Any displaced or unstable 3- or 4-part fracture of the proximal humerus (i.e. segment dis-placement > 0.5 cm or angulated > 45°) except isolated displaced fractures of the greater or lesser tuberosity
- •Primary fracture treatment with a PHILOS plate
- •Ability to understand the content of the patient information / informed consent form
- •Willingness and ability to participate in the clinical investigation including imaging and fol-low-up procedures
- •Signed informed consent
- •Preoperative
排除标准
- •Bilateral or previous proximal humerus fractures on either side
- •Splitting fracture of the humeral head or humeral head impression fracture
- •Cuff-arthropathy of the contra- or ipsilateral proximal humerus
- •Associated nerve or vessel injury
- •Any known clotting disorders, severe cardiac and/or pulmonary insufficiency
- •Known hypersensitivity or allergy to any of the components of Traumacem V+ Cement Kit
- •Any severe systemic disease: class 4 - 6 of the American Society of Anesthesiologists (ASA) physical status classification
- •Any not medically managed severe systemic disease: class 3 of the ASA physical status classification
- •Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- •Intraoperative Exclusion Criteria:
- •Intraoperative decision to use implants other than PHILOS/PHILOS Screw Augmentation
研究组 & 干预措施
PHILOS +
Proximal Humeral Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).
干预措施: PHILOS+ (Device)
PHILOS
Proximal Humeral Internal Locking System (PHILOS)
干预措施: PHILOS (Device)
结局指标
主要结局
Any occurrence of radiographically confirmed mechanical failure during the first year after treatment.
时间窗: one year
Mechanical failures are defined as loss of reduction (≥ 15° increase of varus malposition between the immediate postoperative position and follow-up radiograph, relative change \[5 mm\] of greater or lesser tuberosity compared to the immediate postoperative position), head impaction (≥ 5 mm difference in outer plate edge and tangent of humeral head between immediate post-op and follow-up. The tangent is determined perpendicular to the humeral neck), screw/plate loosening (any change outwards of screw position in relation to immediate postoperative position) and secondary screw perforation (perforation of one or more screws through the humeral head into the joint space on the follow-up radiograph(and lack of screw perforation on the intra- or postoperative Rx based on a baseline anteroposterior and axial Rx.
次要结局
- Surgical details(Intra- /postoperative)
- Description of augmentation details(Intraoperative)
- Shoulder function(Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery)
- Relation of patient factors on mechanical failures(Up to one year)
- Relation of fracture characteristics on mechanical failures(Up to one year)
- Relation of surgical factors on mechanical failures(Up to one year)
- Reoperation rate(Up to one year)
- Intra- and postoperative adverse events related to the procedure and/or device(Up to one year)
- Patient reported outcome (Quality of life)(Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery)
- Surgical details(Intraoperative)