Skip to main content
OpenTrials
Completed

NCT Number: NCT03850665

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedics and Rehabilitation, Medical University of Warsaw, Warsaw, Masovian Voivodeship, Poland

Loading trial locations.

About this study

Patients with primary hip osteoarthritis will be included in a randomized controlled trial and assigned to total hip arthroplasty using one the of hip approaches: anterior or anterolateral. Subjects will be assessed preoperative and 3 and 12 moths postoperative.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Direct Anterior Approach (DAA)

Procedure

Direct Anterior Approach surgery to replace the hip.

Anterolateral approach

Procedure

Anterolateral approach surgery to replace the hip.

Primary outcomes

  1. Change in biomechanical gait parameters

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

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

  2. Gluteus medius muscle fatigue

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

    Surface Electromyographic analysis performed for testing gluteus medius activity

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

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

    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.

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

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

    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.

  5. Change in Oxford scale

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

    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)

  6. Change in SF-36 scale

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

    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).

  7. Change in Visual Analog Scale (VAS) scale

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

    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.

  8. Change in biomechanical gait balance

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

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

  9. Change in biomechanical coordination

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

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

Secondary outcomes

  1. Radiological analysis of implants positioning

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

    To measure angles associated with proper implants positioning

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Comparison of Early Objective and Subjective Outcome in Patients After Hip Arthroplasty, Operated From Direct Anterior, Posterolateraland Anterolateral Approach: Prospective Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2019
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.