Gait After THA: Direct Anterior vs Manual Posterior vs Ro... | NCT07226973 | Trialant

Gait After THA: Direct Anterior vs Manual Posterior vs Ro... | NCT07226973 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Manual Direct Anterior Approach (DAA)	Active Comparator	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)
Manual Posterior Approach	Active Comparator	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)
Robotic-Assisted Posterior Approach	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total hip arthroplasty via direct anterior approach (manual, non-robotic)	Procedure	Primary THA performed via a direct anterior approach without robotic assistance	Manual Direct Anterior Approach (DAA)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Walking speed during level gait (m/s)	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)	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	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 Outcomes

Measure	Description	Time Frame
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)

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23507070	Background	Varin D, Lamontagne M, Beaule PE. Does the anterior approach for THA provide closer-to-normal lower-limb motion? J Arthroplasty. 2013 Sep;28(8):1401-7. doi: 10.1016/j.arth.2012.11.018. Epub 2013 Mar 16.
36719679	Background	Yan L, Ge L, Dong S, Saluja K, Li D, Reddy KS, Wang Q, Yao L, Li JJ, Roza da Costa B, Xing D, Wang B. Evaluation of Comparative Efficacy and Safety of Surgical Approaches for Total Hip Arthroplasty: A Systematic Review and Network Meta-analysis. JAMA Netw Open. 2023 Jan 3;6(1):e2253942. doi: 10.1001/jamanetworkopen.2022.53942.