Clinical trial NCT03850665: Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
Official title: Comparison of Early Objective and Subjective Outcome in Patients After Hip Arthroplasty, Operated From Direct Anterior, Posterolateraland Anterolateral Approach: Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip
Osteoarthritis
Keywords: total
hip
arthroplasty
surgical
approach
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in biomechanical gait parameters
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
measure: Gluteus medius muscle fatigue
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
measure: Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
measure: Change in Oxford scale
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
measure: Change in SF-36 scale
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
measure: Change in Visual Analog Scale (VAS) scale
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
measure: Change in biomechanical gait balance
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
measure: Change in biomechanical coordination
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Secondary outcomes:
measure: Radiological analysis of implants positioning
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Orthopedics and Rehabilitation, Medical University of Warsaw
state: Mazowieckie
city: Warsaw
country: Poland
facility: Orthopaedics and Rehabilitation Department, Medical University of Warsaw
Study officials:
affiliation: Orthopaedics and Rehabilitation Department, Medical University of Warsaw
name: Artur Stolarczyk, Ph. D
role: STUDY_DIRECTOR
affiliation: Orthopaedics and Rehabilitation Department, Medical University of Warsaw
name: Bartosz Maciąg
role: PRINCIPAL_INVESTIGATOR
References:
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