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
- 2
- 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
研究组 & 干预措施
Manual Direct Anterior Approach (DAA)
The DAA utilizes an internervous and intermuscular approach, preserving abductor and posterior soft tissues, and is associated with reduced dislocation rates and accelerated early recovery.⁶ However, it carries a steep learning curve and an elevated risk of lateral femoral cutaneous nerve neuropraxia.
干预措施: Total hip arthroplasty via direct anterior approach (manual, non-robotic) (Procedure)
Manual Posterior Approach
PA remains the most commonly used technique worldwide, offering extensile exposure and preserved abductor function, though its historical association with increased dislocation risk has necessitated meticulous capsular and soft-tissue repair.
干预措施: Total hip arthroplasty via posterior approach (manual, non-robotic) (Procedure)
Robotic-Assisted Posterior Approach
Robotic-assisted THA introduces computer-navigated precision into implant alignment and biomechanical restoration. Contemporary systems (e.g., MAKO) offer intraoperative haptic guidance and preoperative CT-based planning to improve component placement accuracy.
干预措施: Robotic-assisted total hip arthroplasty via posterior approach (Procedure)
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))