Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach

NCT03850665 | Completed

• 1 other identifier: THA/ Warsaw MU
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study will be to compare functional outcomes of the two surgical hip approaches in total hip arthroplasty: anterior, posterolateral and anterolateral. Surgical approach may have influence on patients functional outcome.

Conditions

Hip; Osteoarthritis

Keywords

total; hip; arthroplasty; surgical; approach

Outcome Measures

Primary Outcomes (9)

• Change in biomechanical gait parameters

  Done by a biomechanics lab for patients to test their hip movements

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

• Gluteus medius muscle fatigue

  Surface Electromyographic analysis performed for testing gluteus medius activity

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

• Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)

  This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score. This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  This measures health status as it relates to the hip. There are 3 subscales, pain which score ranges from 0-20, stiffness range from 0-8, physical function ranging from 0-68. The total score is just added up from the subscales.

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

• Change in Oxford scale

  The Oxford scale is a physiotherapist objective-rated scale to asses muscle strength against the resistance. It is graded from 0 (flicker of movement) to 5 (Through full range actively against strong resistance)

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

• Change in SF-36 scale

  The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

• Change in Visual Analog Scale (VAS) scale

  To measure pain. This is a line with left most end representing no pain with the rightmost representing extreme pain. The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100. The line is 100mm long.

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

• Change in biomechanical gait balance

  Done by a biomechanics lab for patients to test their gait balance

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

• Change in biomechanical coordination

  Done by a biomechanics lab for patients to test their hip movements coordination

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

Secondary Outcomes (1)

• Radiological analysis of implants positioning

  from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

Study Arms (3)

Direct Anterior Approach (DAA)

ACTIVE COMPARATOR

Direct Anterior Approach surgery to replace the hip.

Procedure: Direct Anterior Approach (DAA); Procedure: Anterolateral approach

Anterolateral approach

ACTIVE COMPARATOR

Anterolateral Approach surgery to replace the hip.

Procedure: Direct Anterior Approach (DAA); Procedure: Anterolateral approach

Posterolateral approach

ACTIVE COMPARATOR

Posterolateral Approach surgery to replace the hip.

Procedure: Direct Anterior Approach (DAA); Procedure: Anterolateral approach

Interventions

Direct Anterior Approach (DAA) PROCEDURE

Direct Anterior Approach surgery to replace the hip.

Anterolateral approach; Direct Anterior Approach (DAA); Posterolateral approach

Anterolateral approach PROCEDURE

Anterolateral approach surgery to replace the hip.

Anterolateral approach; Direct Anterior Approach (DAA); Posterolateral approach

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient's consent for anticipation in the study
• BMI less than 35
• ability to walk the distance of 10m and stand up from the chair
• arthroplasty in one hip

You may not qualify if:

• patient's lack of consent for anticipation in the study
• neurological diseases
• balance disorders
• reoperations in the area of endoprosthesis
• muscles diseases
• rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis)
• dizziness, vasovagal syncope

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (2)

Department of Orthopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Location

Orthopaedics and Rehabilitation Department, Medical University of Warsaw

Warsaw, Poland

Location

Related Publications (17)

• 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.

  PMID: 21978244 BACKGROUND

• 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.

  PMID: 21843824 BACKGROUND

• 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.

  PMID: 11764347 BACKGROUND

• 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.

  PMID: 23148591 BACKGROUND

• 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: 27687805 BACKGROUND

• 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.

  PMID: 23518430 BACKGROUND

• 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.

  PMID: 27004636 BACKGROUND

• 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.

  PMID: 21075378 BACKGROUND

• 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.

  PMID: 27721093 BACKGROUND

• 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.

  PMID: 26683920 BACKGROUND

• 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.

  PMID: 20541940 BACKGROUND

• 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.

  PMID: 18242996 BACKGROUND

• 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.

  PMID: 19209135 BACKGROUND

• 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.

  PMID: 11550862 BACKGROUND

• 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.

  PMID: 11642645 BACKGROUND

• 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.

  PMID: 16376260 BACKGROUND

• 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.

  PMID: 16259627 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Artur Stolarczyk, Ph. D

  Orthopaedics and Rehabilitation Department, Medical University of Warsaw

  STUDY DIRECTOR

• Bartosz Maciąg

  Orthopaedics and Rehabilitation Department, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Orthopaedics and Rehabilitation, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 15, 2018
• First Posted: February 22, 2019
• Study Start: September 27, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

PL (2)