Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
NCT ID: NCT03850665
Last Updated: 2021-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
140 participants
INTERVENTIONAL
2020-09-27
2021-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement
NCT01106560
A Trial Comparing Mini-posterior Approach and Direct Anterior Approach
NCT01024309
Anterior vs Posterior Approach in THA
NCT03673514
Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA
NCT01616667
The Clinical Outcomes After Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty
NCT03210844
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Biomechanical gait parameters will be collected using tree-dimensional motion analysis system "BTS SMART".
Evaluation of the function of the middle gluteal muscle with superficial EMG (sEMG) percutaneous surface electromyography. Fatigue assessment (mean frequency and amplitude) of the gluteus medius muscle during isometric muscle contraction.
Balance and coordination as well as fall risk will be assessed with use of dynamometric Biodex Balance platform. The study will determine the values of individual indicators: general stability index (OWS), anterior-posterior stability index (APW), the median lateral stability index (MLW) and the fall risk index (RU).
Subjective assessment will be conducted with use of Visual Analogue Scale, WOMAC Index, Oxford Hip Score, The Short Form-36 (SF-36) and Harris Hip Score
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Direct Anterior Approach (DAA)
Direct Anterior Approach surgery to replace the hip.
Direct Anterior Approach (DAA)
Direct Anterior Approach surgery to replace the hip.
Anterolateral approach
Anterolateral approach surgery to replace the hip.
Anterolateral approach
Anterolateral Approach surgery to replace the hip.
Direct Anterior Approach (DAA)
Direct Anterior Approach surgery to replace the hip.
Anterolateral approach
Anterolateral approach surgery to replace the hip.
Posterolateral approach
Posterolateral Approach surgery to replace the hip.
Direct Anterior Approach (DAA)
Direct Anterior Approach surgery to replace the hip.
Anterolateral approach
Anterolateral approach surgery to replace the hip.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Direct Anterior Approach (DAA)
Direct Anterior Approach surgery to replace the hip.
Anterolateral approach
Anterolateral approach surgery to replace the hip.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI less than 35
* ability to walk the distance of 10m and stand up from the chair
* arthroplasty in one hip
Exclusion Criteria
* neurological diseases
* balance disorders
* reoperations in the area of endoprosthesis
* muscles diseases
* rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis)
* dizziness, vasovagal syncope
50 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Warsaw
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Artur Stolarczyk
Head of the Department of Orthopaedics and Rehabilitation, Principal Investigator, Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Artur Stolarczyk, Ph. D
Role: STUDY_DIRECTOR
Orthopaedics and Rehabilitation Department, Medical University of Warsaw
Bartosz Maciąg
Role: PRINCIPAL_INVESTIGATOR
Orthopaedics and Rehabilitation Department, Medical University of Warsaw
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Orthopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Orthopaedics and Rehabilitation Department, Medical University of Warsaw
Warsaw, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mariconda M, Galasso O, Costa GG, Recano P, Cerbasi S. Quality of life and functionality after total hip arthroplasty: a long-term follow-up study. BMC Musculoskelet Disord. 2011 Oct 6;12:222. doi: 10.1186/1471-2474-12-222.
Sinha A, Twycross-Lewis R, Small C, Morrissey D, Maffulli N. Motion analysis as an outcome measure for hip arthroplasty. Surgeon. 2011 Oct;9(5):284-91. doi: 10.1016/j.surge.2011.02.002. Epub 2011 Mar 13.
Demos HA, Rorabeck CH, Bourne RB, MacDonald SJ, McCalden RW. Instability in primary total hip arthroplasty with the direct lateral approach. Clin Orthop Relat Res. 2001 Dec;(393):168-80. doi: 10.1097/00003086-200112000-00020.
Wylde V, Blom AW, Bolink S, Brunton L, Dieppe P, Gooberman-Hill R, Grimm B, Mann C, Lenguerrand E. Assessing function in patients undergoing joint replacement: a study protocol for a cohort study. BMC Musculoskelet Disord. 2012 Nov 13;13:220. doi: 10.1186/1471-2474-13-220.
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.
Queen RM, Schaeffer JF, Butler RJ, Berasi CC, Kelley SS, Attarian DE, Bolognesi MP. Does surgical approach during total hip arthroplasty alter gait recovery during the first year following surgery? J Arthroplasty. 2013 Oct;28(9):1639-43. doi: 10.1016/j.arth.2013.02.008. Epub 2013 Mar 19.
Wesseling M, Meyer C, Corten K, Simon JP, Desloovere K, Jonkers I. Does surgical approach or prosthesis type affect hip joint loading one year after surgery? Gait Posture. 2016 Feb;44:74-82. doi: 10.1016/j.gaitpost.2015.11.009. Epub 2015 Nov 23.
Foucher KC, Wimmer MA, Moisio KC, Hildebrand M, Berli MC, Walker MR, Berger RA, Galante JO. Time course and extent of functional recovery during the first postoperative year after minimally invasive total hip arthroplasty with two different surgical approaches--a randomized controlled trial. J Biomech. 2011 Feb 3;44(3):372-8. doi: 10.1016/j.jbiomech.2010.10.026. Epub 2010 Nov 13.
Rosenlund S, Broeng L, Overgaard S, Jensen C, Holsgaard-Larsen A. The efficacy of modified direct lateral versus posterior approach on gait function and hip muscle strength after primary total hip arthroplasty at 12months follow-up. An explorative randomised controlled trial. Clin Biomech (Bristol). 2016 Nov;39:91-99. doi: 10.1016/j.clinbiomech.2016.09.011. Epub 2016 Sep 30.
Yue C, Kang P, Pei F. Comparison of Direct Anterior and Lateral Approaches in Total Hip Arthroplasty: A Systematic Review and Meta-Analysis (PRISMA). Medicine (Baltimore). 2015 Dec;94(50):e2126. doi: 10.1097/MD.0000000000002126.
Beaulieu ML, Lamontagne M, Beaule PE. Lower limb biomechanics during gait do not return to normal following total hip arthroplasty. Gait Posture. 2010 Jun;32(2):269-73. doi: 10.1016/j.gaitpost.2010.05.007. Epub 2010 Jun 11.
Bennett D, Humphreys L, O'Brien S, Kelly C, Orr JF, Beverland DE. Gait kinematics of age-stratified hip replacement patients--a large scale, long-term follow-up study. Gait Posture. 2008 Aug;28(2):194-200. doi: 10.1016/j.gaitpost.2007.11.010. Epub 2008 Feb 19.
Calo L, Rabini A, Picciotti PM, Laurino S, Passali GC, Ferrara PE, Maggi L, Piazzini DB, Specchia A, Frasca G, Ronconi G, Bertolini C, Scarano E. Postural control in patients with total hip replacement. Eur J Phys Rehabil Med. 2009 Sep;45(3):327-34. Epub 2009 Feb 11.
Soderman P, Malchau H, Herberts P. Outcome of total hip replacement: a comparison of different measurement methods. Clin Orthop Relat Res. 2001 Sep;(390):163-72. doi: 10.1097/00003086-200109000-00019.
McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001 Oct;45(5):453-61. doi: 10.1002/1529-0131(200110)45:53.0.co;2-w. No abstract available.
Kalairajah Y, Azurza K, Hulme C, Molloy S, Drabu KJ. Health outcome measures in the evaluation of total hip arthroplasties--a comparison between the Harris hip score and the Oxford hip score. J Arthroplasty. 2005 Dec;20(8):1037-41. doi: 10.1016/j.arth.2005.04.017.
Wylde V, Learmonth ID, Cavendish VJ. The Oxford hip score: the patient's perspective. Health Qual Life Outcomes. 2005 Oct 31;3:66. doi: 10.1186/1477-7525-3-66.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
THA/ Warsaw MU
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.