Osteoarthritis (OA) of the Hip
Conditions
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.
Interventions
PROCEDURETotal hip arthroplasty via direct anterior approach (manual, non-robotic)
Primary THA performed via a direct anterior approach without robotic assistance
PROCEDURETotal hip arthroplasty via posterior approach (manual, non-robotic)
Primary THA performed via a posterior approach without robotic assistance
PROCEDURERobotic-assisted total hip arthroplasty via posterior approach
Primary THA via posterior approach using pre-op CT-based planning and intra-op robotic assistance
Sponsors
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactGeorge Chimento, MD
Backup ContactKen Bode
Outcome results
None listed