Gait After THA: Direct Anterior vs Manual Posterior vs Robotic Posterior
ConditionOsteoarthritis (OA) of the Hip
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOchsner Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged >18 undergoing primary elective THA for osteoarthritis
BMI <35
Ability to walk unassisted (cane, walker, wheelchair, ect) for > 150 feet preoperatively
Disqualifiers
Previous hip surgery on the affected side
Neurological disorders affecting gait
Contraindication to either DAA or PA
Trial design
Design model
Parallel
Treatments tested in this trial
Total hip arthroplasty via direct anterior approach (manual, non-robotic)
Procedure/SurgeryPrimary THA performed via a direct anterior approach without robotic assistance
Total hip arthroplasty via posterior approach (manual, non-robotic)
Procedure/SurgeryPrimary THA performed via a posterior approach without robotic assistance
Robotic-assisted total hip arthroplasty via posterior approach
Procedure/SurgeryPrimary THA via posterior approach using pre-op CT-based planning and intra-op robotic assistance
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Manual Direct Anterior Approach (DAA)Active comparator 1 intervention
Group B: Manual Posterior ApproachActive comparator 1 intervention
Group C: Robotic-Assisted Posterior ApproachActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Walking speed during level gait (m/s)
Mean self-selected walking speed measured over instrumented walkway during motion-capture trials.
Time frame
Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.2
Peak hip abduction moment during stance (Nm/kg)
Maximum external hip abduction moment during stance, normalized to body mass.
Time frame
Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.3
EMG- Gluteus medius peak activation at initial contact/loading response
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.
Time frame
Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.Secondary outcomes
1
postoperative complications-(participants with ≥1 event, %)
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)
Time frame
through study completion, an average of 1 year2
Patient Reported Outcome Measures-HOOS
Hip Disability and Osteoarthritis Outcome Score. Questionnaire. Range 0-100, higher=better
Time frame
Baseline; 6 weeks; 12 weeks; 12 months; change from baseline - Score (0-100)Sponsors and contacts
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Source ClinicalTrials.gov