A Prospective, Single-Blinded, Partially Randomized Three-Cohort Study Comparing Manual Direct Anterior and Manual Posterior Approaches to a Non-Randomized Robotic Posterior Cohort for Total Hip Arthroplasty Using Gait Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Walking speed during level gait (m/s)
研究概览
简要总结
The purpose of this study is to evaluate the gait biomechanics following THA on 3 groups of subjects undergoing DAA (manual) and PA (manual and robotic) surgical approaches.
详细描述
Single-center, three-arm, partially randomized interventional study comparing gait biomechanics after primary total hip arthroplasty (THA) via (1) manual direct anterior approach (DAA), (2) manual posterior approach (PA), and (3) robotic-assisted posterior approach (rPA). One surgeon's patients are randomized to DAA vs PA; the second surgeon's patients receive rPA per routine practice. Outcomes assessors are blinded (motion-capture suit conceals dressings/scars). Gait and sit-to-stand analyses are performed pre-op and at 6 and 12 weeks post-op using a Vicon motion capture system with force plates and surface EMG. Patient-reported outcomes are collected with standard instruments. The trial evaluates short-term biomechanical recovery and patient-reported outcomes across approaches.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged >18 undergoing primary elective THA for osteoarthritis
- •Ability to walk unassisted (cane, walker, wheelchair, ect) for > 150 feet preoperatively
排除标准
- •Previous hip surgery on the affected side
- •Neurological disorders affecting gait
- •Contraindication to either DAA or PA
结局指标
主要结局
Walking speed during level gait (m/s)
时间窗: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.
Mean self-selected walking speed measured over instrumented walkway during motion-capture trials.
Peak hip abduction moment during stance (Nm/kg)
时间窗: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.
Maximum external hip abduction moment during stance, normalized to body mass.
EMG- Gluteus medius peak activation at initial contact/loading response
时间窗: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.
Peak normalized surface EMG amplitude of the operated-side gluteus medius measured during the initial contact/loading response of level walking. EMG is sampled synchronously with motion capture and force plates, band-pass filtered (\~20-450 Hz), rectified, and low-pass filtered (\~6 Hz) to form a linear envelope. Strides are time-normalized to 0-100% gait cycle; the peak is extracted within 0-10% of the gait cycle (heel strike through loading response). Amplitude is normalized to the participant's maximum voluntary isometric contraction (%MVIC). Participant-level values are the mean of valid trials at each visit.
次要结局
- postoperative complications-(participants with ≥1 event, %)(through study completion, an average of 1 year)
- Patient Reported Outcome Measures-HOOS(Baseline; 6 weeks; 12 weeks; 12 months; change from baseline - Score (0-100))