NCT07226973

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Oct 2025Nov 2027

Study Start

First participant enrolled

October 9, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2027

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

October 28, 2025

Last Update Submit

November 6, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • postoperative complications-(participants with ≥1 event, %)

    through study completion, an average of 1 year

  • Patient Reported Outcome Measures-HOOS

    Baseline; 6 weeks; 12 weeks; 12 months; change from baseline - Score (0-100)

Study Arms (3)

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

Primary THA performed via a direct anterior approach without robotic assistance

Manual Direct Anterior Approach (DAA)

Primary THA performed via a posterior approach without robotic assistance

Manual Posterior Approach

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

Robotic-Assisted Posterior Approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ochsner Health Center - Elmwood

Metairie, Louisiana, 70005, United States

RECRUITING

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

RECRUITING

Related Publications (16)

  • 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: 23507070BACKGROUND
  • 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: 36719679BACKGROUND
  • 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: 25453632BACKGROUND
  • 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: 30736783BACKGROUND
  • 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: 37010580BACKGROUND
  • 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: 28956180BACKGROUND
  • 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: 30808382BACKGROUND
  • 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: 30189881BACKGROUND
  • Fagotti L, Falotico GG, Maranho DA, Ayeni OR, Ejnisman B, Cohen M, Astur DC. POSTERIOR VERSUS ANTERIOR APPROACH TO TOTAL HIP ARTHROPLASTY: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS. Acta Ortop Bras. 2021 Nov-Dec;29(6):297-303. doi: 10.1590/1413-785220212906244610.

    PMID: 34849093BACKGROUND
  • Barrett WP, Turner SE, Leopold JP. Prospective randomized study of direct anterior vs postero-lateral approach for total hip arthroplasty. J Arthroplasty. 2013 Oct;28(9):1634-8. doi: 10.1016/j.arth.2013.01.034. Epub 2013 Mar 19.

    PMID: 23523485BACKGROUND
  • Cheng TE, Wallis JA, Taylor NF, Holden CT, Marks P, Smith CL, Armstrong MS, Singh PJ. A Prospective Randomized Clinical Trial in Total Hip Arthroplasty-Comparing Early Results Between the Direct Anterior Approach and the Posterior Approach. J Arthroplasty. 2017 Mar;32(3):883-890. doi: 10.1016/j.arth.2016.08.027. Epub 2016 Aug 31.

    PMID: 27687805BACKGROUND
  • Rosenlund S, Broeng L, Holsgaard-Larsen A, Jensen C, Overgaard S. Patient-reported outcome after total hip arthroplasty: comparison between lateral and posterior approach. Acta Orthop. 2017 Jun;88(3):239-247. doi: 10.1080/17453674.2017.1291100. Epub 2017 Feb 18.

    PMID: 28464754BACKGROUND
  • Meneghini RM, Smits SA, Swinford RR, Bahamonde RE. A randomized, prospective study of 3 minimally invasive surgical approaches in total hip arthroplasty: comprehensive gait analysis. J Arthroplasty. 2008 Sep;23(6 Suppl 1):68-73. doi: 10.1016/j.arth.2008.05.014.

    PMID: 18722305BACKGROUND
  • Petis S, Howard J, Lanting B, Jones I, Birmingham T, Vasarhelyi E. Comparing the anterior, posterior and lateral approach: gait analysis in total hip arthroplasty. Can J Surg. 2018 Feb;61(1):50-57. doi: 10.1503/cjs.003217. Epub 2017 Dec 1.

    PMID: 29368677BACKGROUND
  • Reininga IH, Stevens M, Wagenmakers R, Boerboom AL, Groothoff JW, Bulstra SK, Zijlstra W. Comparison of gait in patients following a computer-navigated minimally invasive anterior approach and a conventional posterolateral approach for total hip arthroplasty: a randomized controlled trial. J Orthop Res. 2013 Feb;31(2):288-94. doi: 10.1002/jor.22210. Epub 2012 Aug 8.

    PMID: 22886805BACKGROUND
  • Nelms NJ, Birch CE, Halsey DH, Blankstein M, McGinnis RS, Beynnon BD. Assessment of Early Gait Recovery After Anterior Approach Compared to Posterior Approach Total Hip Arthroplasty: A Smartphone Accelerometer-Based Study. J Arthroplasty. 2020 Feb;35(2):465-470. doi: 10.1016/j.arth.2019.09.030. Epub 2019 Sep 26.

    PMID: 31629624BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • George Chimento, MD

    Ochsner Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2025

First Posted

November 12, 2025

Study Start

October 9, 2025

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

November 15, 2027

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations