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

November 6, 2025 updated by: Ochsner Health System

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Total hip arthroplasty via direct anterior approach (manual, non-robotic)
Primary THA performed via a direct anterior approach without robotic assistance
Active Comparator: 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.
Procedure: Total hip arthroplasty via posterior approach (manual, non-robotic)
Primary THA performed via a posterior approach without robotic assistance
Active Comparator: 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.
Procedure: Robotic-assisted total hip arthroplasty via posterior approach
Primary THA via posterior approach using pre-op CT-based planning and intra-op robotic assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.
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.
Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.
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.
Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 1 year
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
Baseline; 6 weeks; 12 weeks; 12 months; change from baseline - Score (0-100)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Investigators

  • Principal Investigator: George Chimento, MD, Ochsner Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2025

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

October 28, 2025

First Submitted That Met QC Criteria

November 6, 2025

First Posted (Actual)

November 12, 2025

Study Record Updates

Last Update Posted (Actual)

November 12, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025.027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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