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

M

Medical University of Warsaw

Status

Completed

Conditions

Osteoarthritis
Hip

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03850665
THA/ Warsaw MU

Details and patient eligibility

About

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.

Full 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

Enrollment

140 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 3 patient groups

Direct Anterior Approach (DAA)
Active Comparator group
Description:
Direct Anterior Approach surgery to replace the hip.
Treatment:
Procedure: Direct Anterior Approach (DAA)
Procedure: Anterolateral approach
Anterolateral approach
Active Comparator group
Description:
Anterolateral Approach surgery to replace the hip.
Treatment:
Procedure: Direct Anterior Approach (DAA)
Procedure: Anterolateral approach
Posterolateral approach
Active Comparator group
Description:
Posterolateral Approach surgery to replace the hip.
Treatment:
Procedure: Direct Anterior Approach (DAA)
Procedure: Anterolateral approach

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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