An interventional study of Direct Anterior Approach (DAA) and Anterolateral approach in Hip and Osteoarthritis, sponsored by Medical University of Warsaw. Completed at 2 sites in Poland. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-06.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Diagnostic
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.
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
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 140 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Direct Anterior Approach surgery to replace the hip.
Procedure: Direct Anterior Approach (DAA) · Procedure: Anterolateral approach
Anterolateral Approach surgery to replace the hip.
Procedure: Direct Anterior Approach (DAA) · Procedure: Anterolateral approach
Posterolateral Approach surgery to replace the hip.
Procedure: Direct Anterior Approach (DAA) · Procedure: Anterolateral approach
Direct Anterior Approach surgery to replace the hip.
Anterolateral approach surgery to replace the hip.
Change in biomechanical gait parameters
Done by a biomechanics lab for patients to test their hip movements
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Radiological analysis of implants positioning
To measure angles associated with proper 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
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw