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NCT Number: NCT07226973

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

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.

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Key information

Conditions

Osteoarthritis (OA) of the Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ochsner Health Center - Elmwood, Metairie, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total hip arthroplasty via direct anterior approach (manual, non-robotic)

Procedure

Primary THA performed via a direct anterior approach without robotic assistance

Total hip arthroplasty via posterior approach (manual, non-robotic)

Procedure

Primary THA performed via a posterior approach without robotic assistance

Robotic-assisted total hip arthroplasty via posterior approach

Procedure

Primary THA via posterior approach using pre-op CT-based planning and intra-op robotic assistance

Primary outcomes

  1. Walking speed during level gait (m/s)

    Time frame: 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.

  2. Peak hip abduction moment during stance (Nm/kg)

    Time frame: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.

    Maximum external hip abduction moment during stance, normalized to body mass.

  3. EMG- Gluteus medius peak activation at initial contact/loading response

    Time frame: 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 outcomes

  1. postoperative complications-(participants with ≥1 event, %)

    Time frame: 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)

  2. Patient Reported Outcome Measures-HOOS

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

George Chimento, MD

CONTACT

[email protected]

504-736-4800

Ken Bode

CONTACT

[email protected]

504-842-1936

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2025
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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