Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Functional Ability
研究概览
简要总结
The goal of this clinical trial is to assess the feasibility of conducting a larger study comparing single implant fixation (SIF) and dual implant fixation (DIF) for treating distal femur fractures (DFF) in older or compromised adults. It will also evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:
- Can DIF improve patient outcomes compared to SIF in older or compromised adults?
- How feasible is it to recruit and retain participants for this trial?
Participants will:
- Be randomly assigned to receive either SIF or DIF for their DFF treatment
- Visit the clinic for follow-ups and assessments of their recovery and bone healing, including potential ultrasound imaging for detecting complications like non-union.
详细描述
The Investigators aim to conduct a multi-centre, preliminary RCT to determine the feasibility and inform the design of a definitive trial comparing patient-important outcomes between patients aged 40 years and older with distal femur fractures managed with SIF vs. DIF.
Primary Aim: Evaluate the feasibility of conducting a larger, definitive trial examining outcomes following SIF vs. DIF for DFFs in older or compromised adults. Our primary outcomes for this objective will be 1) recruitment and retention at the participating sites; and 2) site investigator feedback regarding barriers to protocol adherence.
Secondary Aims: Pilot the collection of candidate outcome measures to determine the optimal primary end point and sample size for a definitive trial. Our primary outcome for this objective will be the Oxford Knee Score, and secondary outcomes will include a range of patient-reported quality of life (QOL) measures, and objective clinical measures.
In addition, the study includes an ultrasound sub-study aimed at evaluating the feasibility of using ultrasound imaging to monitor bone healing and detect complications like non-union in patients with DFF.
Participants will be randomly assigned to receive either SIF or DIF, with SIF generally involving a single implant (such as a lateral locked plate or retrograde intramedullary nail) and DIF using a combination of implants (e.g., dual plates or a nail and plate). This randomized design will enable us to assess whether dual implant fixation offers improved clinical outcomes, such as reduced morbidity and faster weight-bearing recovery, compared to the more traditional single implant fixation.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and
- •Rorabeck type 1, 2) and either:
- •Age ≥ 60 years or;
- •Age 18-60 years with one or more of:
- •i. Osteoporosis ii. Obesity (Body Mass Index >30) iii. Metaphyseal comminution iv. Diabetes
- •Fracture amenable to plating and nailing
- •Ability to read and speak English or availability of a translator
- •Acute fractures (within 14-days of injury)
- •No surgeon preference regarding SIF vs. DIF
- •Provision of informed consent
排除标准
- •Candidate for primary or revision arthroplasty (surgeon opinion)
- •Periprosthetic fracture with loose implant
- •Gustillo grade III open fractures
- •Ipsilateral hip implant
- •Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)
- •Non-ambulatory patients
- •Multi-trauma patient (Injury Severity Score ≥ 16)
- •Lack of bone substance or poor bone-quality which, in the surgeon's judgment, makes fixation impossible
- •Any concomitant lower-extremity injury
- •Inability to obtain informed consent due to language barrier
结局指标
主要结局
Functional Ability
时间窗: 2 year
Via the validated Oxford Knee Score. It ranges from 0 to 48, with higher scores indicating better outcomes (i.e., less pain and better function).
Feasibility Outcomes - Recruitment
时间窗: Through study completion, an average of 1 year.
Recruitment - 1) Recruitment (number of patients enrolled per-month). Success will be considered as each site enrolling a minimum mean of 0.6 patients per-month. This is a conservative estimate based on our previous trials in similar populations, and we expect that each site will screen a minimum of twice this number. * Number of patients enrolled per month * Success if each site able to enroll mean of 0.6 patients per month
Feasibility Outcomes - Retention
时间窗: Through study completion, an average of 1 year.
Retention - (proportion of patients that complete one-year follow-up). Success will be considered a minimum of 85% of patients with complete one-year data. * Proportion of patients that complete 1 year follow up * Success: 85%
次要结局
- Functional ability(2 years)
- Weight-bearing(2 years)
- Mobility(3, 6, 12 and 24 months.)
- Health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).(2 years)
- Health-resource utilization(2 years)
- Complications(2 years)
- Re-operations (Type)(2 years)
- Re-operations (Reason)(2 years)
- Data quality(Through study completion, an average of 24 months.)
- Randomization errors/cross-overs(Through study completion, an average of 24 months.)
- The proportion of patients instructed to WBAT in each group(Through study completion, an average of 24 months.)
- Barriers to protocol adherence(Through study completion, an average of 24 months.)
- Pain rating(2 years)
- Radiographic(2 years)
- Successful initiation of sites(Through study completion, an average of 24 months.)