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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Total hip arthroplasty via direct anterior approach (manual, non-robotic)
  Primary THA performed via a direct anterior approach without robotic assistance
• Процедура Total hip arthroplasty via posterior approach (manual, non-robotic)
  Primary THA performed via a posterior approach without robotic assistance
• Процедура Robotic-assisted total hip arthroplasty via posterior approach
  Primary THA via posterior approach using pre-op CT-based planning and intra-op robotic assistance

Первичные конечные точки

• Walking speed during level gait (m/s) [Срок оценки: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.]
• Peak hip abduction moment during stance (Nm/kg) [Срок оценки: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.]
• EMG- Gluteus medius peak activation at initial contact/loading response [Срок оценки: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.]

Вторичные конечные точки (2)

• postoperative complications-(participants with ≥1 event, %) [Срок оценки: through study completion, an average of 1 year]
• Patient Reported Outcome Measures-HOOS [Срок оценки: Baseline; 6 weeks; 12 weeks; 12 months; change from baseline - Score (0-100)]

Критерии участия

Критерии включения

• Adults aged >18 undergoing primary elective THA for osteoarthritis
• BMI <35
• Ability to walk unassisted (cane, walker, wheelchair, ect) for > 150 feet preoperatively

Критерии исключения

• Previous hip surgery on the affected side
• Neurological disorders affecting gait
• Contraindication to either DAA or PA

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Ochsner Health Center - Elmwood — Metairie
• Ochsner Medical Center — New Orleans

Публикации

• 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. PMID 23507070
• 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. PMID 36719679
• Higgins BT, Barlow DR, Heagerty NE, Lin TJ. Anterior vs. posterior approach for total hip arthroplasty, a systematic review and meta-analysis. J Arthroplasty. 2015 Mar;30(3):419-34. doi: 10.1016/j.arth.2014.10.020. Epub 2014 Oct 22. PMID 25453632
• Yoo JI, Cha YH, Kim KJ, Kim HY, Choy WS, Hwang SC. Gait analysis after total hip arthroplasty using direct anterior approach versus anterolateral approach: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2019 Feb 8;20(1):63. doi: 10.1186/s12891-019-2450-2. PMID 30736783
• Ang JJM, Onggo JR, Stokes CM, Ambikaipalan A. Comparing direct anterior approach versus posterior approach or lateral approach in total hip arthroplasty: a systematic review and meta-analysis. Eur J Orthop Surg Traumatol. 2023 Oct;33(7):2773-2792. doi: 10.1007/s00590-023-03528-8. Epub 2023 Apr 3. PMID 37010580
• Putananon C, Tuchinda H, Arirachakaran A, Wongsak S, Narinsorasak T, Kongtharvonskul J. Comparison of direct anterior, lateral, posterior and posterior-2 approaches in total hip arthroplasty: network meta-analysis. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):255-267. doi: 10.1007/s00590-017-2046-1. Epub 2017 Sep 27. PMID 28956180
• Wang Z, Bao HW, Hou JZ. Direct anterior versus lateral approaches for clinical outcomes after total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2019 Feb 26;14(1):63. doi: 10.1186/s13018-019-1095-z. PMID 30808382
• Wang Z, Hou JZ, Wu CH, Zhou YJ, Gu XM, Wang HH, Feng W, Cheng YX, Sheng X, Bao HW. A systematic review and meta-analysis of direct anterior approach versus posterior approach in total hip arthroplasty. J Orthop Surg Res. 2018 Sep 6;13(1):229. doi: 10.1186/s13018-018-0929-4. PMID 30189881

Идентификаторы

NCT: NCT07226973 · 2025.027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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