Hip, Osteoarthritis
Conditions
Keywords
total, hip, arthroplasty, surgical, approach
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.
Detailed description
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
Interventions
PROCEDUREDirect Anterior Approach (DAA)
Direct Anterior Approach surgery to replace the hip.
PROCEDUREAnterolateral approach
Anterolateral approach surgery to replace the hip.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in biomechanical coordination | 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 |
| Change in biomechanical gait parameters | 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 |
| Gluteus medius muscle fatigue | 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 |
| Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL) | 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. |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. |
| Change in Oxford scale | 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) |
| Change in SF-36 scale | 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). |
| Change in Visual Analog Scale (VAS) scale | 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. |
| Change in biomechanical gait balance | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | To measure angles associated with proper implants positioning |
Countries
Poland
Outcome results
None listed