Prospective Multicenter Registry for Use of the MAXFRAME™ Multiaxial Correction System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Type of surgery
研究概览
简要总结
The aim of this international, prospective, multicenter case series (patient registry) is to gather the first evidence on the use of the MAXFRAME™ system in normal clinical settings during deformity correction of both, the upper and lower limb, and gain information on indications, the handling of the device from the patients' and surgeons' perspective, as well as number of re-planning needed.
It is planned to prospectively follow up to 100 patients treated with the MAXFRAME™ system. Information on patients entered into the registry will be collected from before the surgery until the removal of the device.
详细描述
The newly developed MAXFRAME™ system from DePuy Synthes® is a multi-Axial correction system based on the hexapod configuration. The indications for the MAXFRAME™ include, but are not limited to, the treatment of open or closed fractures of long bones, pseudarthrosis, limb lengthening via epiphyseal or metaphyseal distraction, joint arthrodesis, to bridge infected fractures or non-unions, to correct bony or soft tissue deformities, and to correct of segmental defects. One of the main novelties of this system is the Perspective Frame Matching (PFM) technique. This software system uses the post-operative x-rays with the entire frame mounted to the bone to generate a 3D visualization of the frame and the exact mounting parameters as well as a representation of the deformity with regards to the position within the frame. This system generates a treatment plan according to the exact representation of the frame, and the deformity at the starting point of the correction. The risk of a frame mal-positioning is reduced, which in return is believed to reduce the risk of a false correction and hopefully leads to a more precise result. Further, this reduces the need for adaptations to the initial treatment protocol, which require repeated radiological assessment and may alienate the patient during the whole process of the deformity correction.
To the investigator's knowledge there are no published studies investigating the accuracy of this method, therefore the aim of the proposed prospective multicenter registry is to gather first evidence on the use of the MAXFRAME™ system in clinical settings and gain information on indications, handling, the number of re-planning's needed, and treatment related adverse events.
Up to 100 patients treated with the MAXFRAME™ system are planned to be included for two years enrollment period. Each patient will be followed up from before the surgery until the removal of the device.
All follow-up visits are according to standard of care. There are fixed time points (visits) during a normal deformity correction process and follow-up:
- Baseline = pre-operative assessment
- Surgery = application of the frame (defined as day 0)
- Post-OP = post-operative image assessment (for PFM planning)
- Frame removal (including conversion, if applicable)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient undergoing surgical treatment (primary or revision) for deformity correction using the MAXFRAME™ system
- •Informed consent obtained, i.e.:
- •Ability to understand the content of the patient information/ICF
- •Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
- •Signed and dated IRB/EC-approved written informed consent OR
- •Written consent provided according to defined and IRB/EC approved procedures for patients who are not able to provide independent written informed consent
排除标准
- •Participation in any other medical device or medicinal product study within the previous month that could influence the treatment observed in this registry
- •Pregnancy
- •Intraoperative decision to use another device than MAXFRAMETM
结局指标
主要结局
Type of surgery
时间窗: Day of surgery until removal of the device (standard approximately 6 months)
primary or revision surgery
Ante- or retro-curvature correction assessment
时间窗: baseline until the removal of the device (standard approximately 6 months)
Ante- or retro-curvature correction (in degrees)
End of deformity correction
时间窗: baseline until the removal of the device (standard approximately 6 months)
Length gained (real (mm) according to the lengthened bone)
Radiological assessments
时间窗: baseline until the removal of the device (standard approximately 6 months)
Radiological assessment according to the measured anatomical angles (degree)
Varus or valgus correction assessment
时间窗: baseline until the removal of the device (standard approximately 6 months)
Varus or valgus correction (in degrees)
Baseline characteristics
时间窗: baseline until the removal of the device (standard approximately 6 months)
Demographics, medical history
Bone lengthening measurement
时间窗: baseline until the removal of the device (standard approximately 6 months)
Bone lengthening (in mm)
Rotational correction assessment
时间窗: baseline until the removal of the device (standard approximately 6 months)
Rotational correction (in degrees)
Reason for changes of treatment plan
时间窗: baseline until the removal of the device (standard approximately 6 months)
reason for any treatment plan changes
Bone union / fusion assessment
时间窗: removal of the device (standard approximately 6 months)
Bone union / fusion (in the case of an arthrodesis)
Radiological assessments of deformity parameters
时间窗: baseline until the removal of the device (standard approximately 6 months)
deformity parameters depending on the level of the deformity (degree)
Assessment of the surgeon and patients experience with the MAXFRAME™ system
时间窗: removal of the device (standard approximately 6 months)
Survey with four questions to rate via numeric rating scale (0= not satisfied at all ; 10= totally satisfied)
次要结局
未报告次要终点