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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Primary THA performed via a direct anterior approach without robotic assistance
Primary THA performed via a posterior approach without robotic assistance
Primary THA via posterior approach using pre-op CT-based planning and intra-op robotic assistance
Ochsner Health Center - Elmwood
Metairie, Louisiana, United States
RECRUITINGOchsner Medical Center
New Orleans, Louisiana, United States
RECRUITINGWalking speed during level gait (m/s)
Mean self-selected walking speed measured over instrumented walkway during motion-capture trials.
Time frame: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.
Peak hip abduction moment during stance (Nm/kg)
Maximum external hip abduction moment during stance, normalized to body mass.
Time frame: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.
EMG- Gluteus medius peak activation at initial contact/loading response
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.
Time frame: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.
postoperative complications-(participants with ≥1 event, %)
Postoperative complications include, but are not limited to: Surgical \& Local Complications Dislocation Prosthetic Joint Infection (Early or Late) Aseptic Loosening Periprosthetic Fracture Implant Wear (Osteolysis) Wound Complications (Hematoma, Dehiscence) Nerve or Vascular Injury Leg Length Discrepancy Heterotopic Ossification Implant Failure or Breakage Adverse Local Tissue Reaction (Metallosis) Tendon/Muscle Dysfunction Medical \& Systemic Complications Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Cardiovascular Events (Heart Attack, Stroke)
Time frame: through study completion, an average of 1 year
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Patient Reported Outcome Measures-HOOS
Hip Disability and Osteoarthritis Outcome Score. Questionnaire. Range 0-100, higher=better
Time frame: Baseline; 6 weeks; 12 weeks; 12 months; change from baseline - Score (0-100)