Recruiting

THA with DAA, PA

Sponsor:

Ochsner Health System

Code:

NCT07226973

Conditions

Osteoarthritis (OA) of the Hip

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Robotic-assisted total hip arthroplasty via posterior approach

Study Details

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.

Conditions

Osteoarthritis (OA) of the Hip

Study ID

NCT07226973

Start date

Oct 9, 2025

Status verified date

Nov, 2025

Completion date

Nov 15, 2027

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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

Primary THA performed via a direct anterior approach without robotic assistance

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

Primary THA performed via a posterior approach without robotic assistance

Robotic-assisted total hip arthroplasty via posterior approach

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

Primary outcome measure

  • Walking speed during level gait (m/s) [ Time Frame: 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

George Chimento, MD

504-736-4800gchimento@ochsner.org

Ken Bode

504-842-1936ken.bode@ochsner.org

Locations

Ochsner Health Center - Elmwood

Recruiting

Metairie, Louisiana, United States, 70005

Contacts

Miguel Jaramillo

504-703-8002miguel.jaramilloforero@ochsner.org

Ochsner Medical Center

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Miguel Jaramillo

504-703-8002miguel.jaramilloforero@ochsner.org

More Information

Sponsor

Ochsner Health System

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2025-11-12.