Osteoarthritis (OA) of the HipNCT07226973
Gait After THA: Direct Anterior vs Manual Posterior vs Robotic Posterior
A study testing Total hip arthroplasty via direct anterior approach (manual, non-robotic), Total hip arthroplasty via posterior approach (manual, non-robotic) and Robotic-assisted total hip arthroplasty via posterior approach in people with Osteoarthritis (OA) of the Hip, run by Ochsner Health System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Hip
- What is being tested?
- Total hip arthroplasty via direct anterior approach (manual, non-robotic), Total hip arthroplasty via posterior approach (manual, non-robotic) and Robotic-assisted total hip arthroplasty via posterior approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Oct 2025to 15 Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged >18 undergoing primary elective THA for osteoarthritis
- BMI <35
- Ability to walk unassisted (cane, walker, wheelchair, ect) for > 150 feet preoperatively
Who cannot join
- Previous hip surgery on the affected side
- Neurological disorders affecting gait
- Contraindication to either DAA or PA
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ochsner Health Center - Elmwood
Metairie, Louisiana, 70005
Miguel Jaramillo, 504-703-8002, miguel.jaramilloforero@ochsner.org
- Recruiting
Ochsner Medical Center
New Orleans, Louisiana, 70121
Miguel Jaramillo, 504-703-8002, miguel.jaramilloforero@ochsner.org
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Osteoarthritis (OA) of the Hip
- Being tested
- Total hip arthroplasty via direct anterior approach (manual, non-robotic), Total hip arthroplasty via posterior approach (manual, non-robotic), Robotic-assisted total hip arthroplasty via posterior approach
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplasty via direct anterior approach (manual, non-robotic)Procedure or surgery
Primary THA performed via a direct anterior approach without robotic assistance
Total hip arthroplasty via posterior approach (manual, non-robotic)Procedure or surgery
Primary THA performed via a posterior approach without robotic assistance
Robotic-assisted total hip arthroplasty via posterior approachProcedure or surgery
Primary THA via posterior approach using pre-op CT-based planning and intra-op robotic assistance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Robotic-assisted total hip arthroplasty via posterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed during level gait (m/s)
Mean self-selected walking speed measured over instrumented walkway during motion-capture trials.
Measured: 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.
Measured: 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.
Measured: Change from baseline (pre-op) to 6 weeks and 12 weeks post-op.
Secondary outcomes (2)
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)
Measured: through study completion, an average of 1 year
Patient Reported Outcome Measures-HOOS
Hip Disability and Osteoarthritis Outcome Score. Questionnaire. Range 0-100, higher=better
Measured: Baseline; 6 weeks; 12 weeks; 12 months; change from baseline - Score (0-100)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start9 Oct 2025
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Chimento, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226973
- Sponsor's protocol ID
- 2025.027
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23507070Yan 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.
PubMed 36719679Higgins 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.
PubMed 25453632Yoo 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.
PubMed 30736783Ang 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.
PubMed 37010580Putananon 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.
PubMed 28956180Wang 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.
PubMed 30808382Wang 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.
PubMed 30189881Fagotti 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.
PubMed 34849093Barrett 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.
PubMed 23523485Cheng 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.
PubMed 27687805Rosenlund 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.
PubMed 28464754Meneghini 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.
PubMed 18722305Petis 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.
PubMed 29368677Reininga 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.
PubMed 22886805