Gait After THA: Direct Anterior vs Manual Posterior vs Robotic Posterior

Not Applicable

Recruiting

• Conditions: Osteoarthritis (OA) of the Hip

• Registration Number: NCT07226973
• Lead Sponsor: Ochsner Health System

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2025-10-09
• Study First Submitted: 2025-10-28
• Status Verified: 2025-11
• Study First Submitted QC: 2025-11-06
• Last Update Submitted: 2025-11-06
• Study First Posted: 2025-11-12
• Last Update Posted: 2025-11-12
• Primary Completion: 2027-11-15
• Study Completion: 2027-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Adults aged >18 undergoing primary elective THA for osteoarthritis
• BMI <35
• Ability to walk unassisted (cane, walker, wheelchair, ect) for > 150 feet preoperatively

Exclusion Criteria

• Previous hip surgery on the affected side
• Neurological disorders affecting gait
• Contraindication to either DAA or PA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Walking speed during level gait (m/s)	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)	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	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.

Secondary Outcome Measures

Name	Time	Method
postoperative complications-(participants with ≥1 event, %)	through study completion, an average of 1 year	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)
Patient Reported Outcome Measures-HOOS	Baseline; 6 weeks; 12 weeks; 12 months; change from baseline - Score (0-100)	Hip Disability and Osteoarthritis Outcome Score. Questionnaire. Range 0-100, higher=better

Trial Locations

Locations (2)

Ochsner Health Center - Elmwood; 🇺🇸 Metairie, Louisiana, United States

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States