Does an Integrated Dual Screw Design Improve Biomechanics and Function Following Fixation of Unstable Intertrochanteric Femur Fractures: a Randomized Pilot Trial (InterTAN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in self-reported physical function
研究概览
简要总结
The goal of this pilot, patient blinded randomized trial is to develop a mechanistic understanding of gait following fixation of unstable intertrochanteric hip fractures and return to function and pain control. The guiding hypothesis that will be tested in a subsequent clinical trial is that the InterTAN when compared to standard lag-screw cephalomedullary nails will have decreased post operative pain, earlier return to symmetric weight bearing, and quicker return to pre-injury functioning levels.
详细描述
Aim 1: Determine the feasibility of conducting a randomized trial assessing gait mechanics as well as outcomes following unstable intertrochanteric femur fractures treated with cephalomedullary nails. This will be achieved by performing a pilot randomized trial comparing the InterTAN versus a single-screw design cephalomedullary nail (SSCMN). Deliverable: Preliminary data to support a larger randomized trial powered on either mechanical assessments or patient reported outcomes. Feasibility of conducting comprehensive biomechanical and patient related outcome measurements in the geriatric hip fracture population.
Aim 2: Determine the pathway to return to function and symmetric weight bearing. Load bearing will be assessed through insole monitoring during their inpatient stay and 2-weeks post-op. Additionally, analysis will be performed to measure gait for hip motion, loading, strength and functional assessments at 6,12, and 26 weeks post-op. Patients will also be assessed at 1-year for reported function as well. Hypothesis: Patients in the InterTAN group will have faster return to symmetrical weight bearing/motion and earlier return to function. Deliverable: Longitudinal data assessing return to function and weight bearing in intertrochanteric femur fractures.
Aim 3: Determine if use of the InterTAN device when compared to SSCMN results in decreased pain following unstable intertrochanteric femur fractures. Patients will be enrolled in a prospective trial with standardized pain control regimen, assessing patients for pain during their hospital stay using Area Under the Curve Analysis of Visual Analogue Pain Scores at 24, 48 and 72 hours. Similarly, opioid usage in morphine milligram equivalents will be assessed. Pain will be assessed at follow-up visits 6, 12, 26, 52 weeks. Hypothesis: The InterTAN will result in decreased pain in the immediate post-operative period and in sub-acute post-operative period.
Aim 4: Determine if the use of the InterTAN device when compared to SSCMN results in decreased healthcare utilization. Participation with therapy, hospital length of stay, discharge disposition, and time-spent in rehabilitation facility will be assessed. Hypothesis: Patients in the InterTAN group will be more likely to be discharged home, participate with therapy more, have decreased length of stay in both inpatient and outpatient units. Deliverable: Data to inform the power analysis for a larger prospective clinical trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-pathologic fractures
- •OTA/AO classification 31A2, 31A3 fractures
- •Ability to participate in 4-MET equivalent activities without ambulatory assistance prior to injury
排除标准
- •Inability to consent
- •Inability to participate in follow-up activities
- •History of chronic pain / current opioid treatment
- •Pre-injury ambulatory status requiring assistance device
- •Neurological condition altering gait or sensation (e.g. History of stroke with altered gait, peripheral neuropathy).
研究组 & 干预措施
Trigen InterTan
Patients in this arm will be implanted with the cephalomedullary nail Trigen InterTan manufactured by Smith & Nephew.
干预措施: Trigen InterTAN (Device)
Synthes TFNA
Patients in this arm will be implanted with the single-screw device TFNA manufactured by DePuy Synthes.
干预措施: Synthes TFNA (Device)
结局指标
主要结局
Change in self-reported physical function
时间窗: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
Change in self-reported pain
时间窗: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Questionnaire is a 56 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates increased interference due to pain.
次要结局
- Change in pain assessment(2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months)
- Change in weight bearing(2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months)
- Change in Functional Independence Measure(2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months)
- Change in Visual Analog Pain Score(2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months)
研究者
Paul E. Matuszewski
Associate Professor
University of Kentucky