Evaluation of Femoral Neck Fracture Migration After Internal Fixation With an Angle Stable Implant Compared With Gold Standard Cannulated Cancellous Screws in Young Adults: Study Protocol for a Clinical RCT Using Radiostereometric Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Static fracture migration
研究概览
简要总结
The goal of the clinical trial is to compare different surgical methods for internal fixation of femoral neck fractures in younger adults.
The main question it aims to answer is:
Is internal fixation with the novel implant consisting of three angle stable screws locked together by a plate equal to internal fixation with cancellous screws or a sliding hip screw in younger adults under 65 years of age in terms of fracture migration?
The study will examine how stable the fracture remains during healing. This will be measured by assessing how much the fracture moves after surgery using a highly precise imaging method called radiostereometric analysis (RSA). The study will also record complications and evaluate pain, health related quality of life, and hip function over time.
The participants will be treated with either a novel angle stable implant (Dynaloc), cannulated cancellous screws or sliding hip screw and followed up at 6 weeks, 12 weeks, 6 months and 12 months. Recruitment will continue until 75 participants, 25 in each group, have completed the 12-week follow-up for the primary outcome.
详细描述
Objective The overall purpose of the study is to assess internal fixation methods for femoral neck fractures in adults under 65 years of age. The primary objective is to compare fracture migration following internal fixation with a novel angle-stable implant (Dynaloc, Swemac) and cannulated cancellous screws (CCS), using fracture migration as the primary outcome.
In addition, a cohort of patients treated with a sliding hip screw (SHS) as part of standard care will be included to provide an additional basis for comparison.
Dynaloc, CCS, and SHS are all CE-marked medical devices used in accordance with the manufacturers' intended use.
Trial design The study is designed as a multicentre, single-blinded randomised controlled trial with radiostereometric analysis (RSA), including an additional prospective cohort.
Patients undergoing internal fixation with Dynaloc or CCS will be randomised, while patients treated with a sliding hip screw will be followed as a separate cohort using the same imaging and follow-up protocol.
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
- Double (Participant, Care Provider)
盲法说明
Randomisation groups will be kept blinded during statical analyses.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Femoral neck fracture (DS720)
- •Age 18-64 years
- •Ability to speak and read Danish
- •Willingness to participate
排除标准
- •Pathological, basicervical or transcervical fracture
- •Clinical Frailty Scale ≥5, indicating mild to severe frailty prior to the fracture
- •Cognitive impairment that hinders informed consent
- •Previous fracture in the ipsilateral femur
- •Patients who are unwilling or incapable of following post-operative care instructions.
- •Comorbidities making the participant ineligible for internal fixation such as:
- •Material sensitivity, documented or suspected
- •Active or suspected latent infection, sepsis or marked local inflammation in or around the surgical area
- •Compromised vascularity, inadequate skin or neurovascular status
- •Compromised bone stock that cannot provide adequate support and/or fixation of the device due to disease, infection or prior implantation
- •Other physical, mental, medical or surgical conditions that would preclude the potential benefit of surgery.
研究组 & 干预措施
Dynaloc
Randomisation
干预措施: Dynaloc implant (Device)
Cannulated cancellous screws
Randomisation
干预措施: Cannulated cancellous screws (Device)
Sliding hip screw
Prospective cohort
干预措施: Sliding hip screw (Device)
结局指标
主要结局
Static fracture migration
时间窗: 12 weeks
Static non-weight bearing fracture migration in a supine set-up
次要结局
- EQ-5D-5L(Baseline, 6 weeks, 12 weeks)
- New mobility score(Baseline, 6 weeks, 12 weeks)
- Modified Harris Hip Score(Baseline, 6 weeks, 12 weeks)
- Pain VRS(Baseline, 6 weeks, 12 weeks)
- Reoperation(0-12 weeks)
- Complication(0-12 weeks)
- Static fracture migration(6 weeks)
- Mortality(0-12 weeks)
研究者
Michaela Manalili Hansen
Medical Doctor
Odense University Hospital