Skip to main content
OpenTrials
Completed

NCT Number: NCT06538519

Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty.

The goal of this Prospective Randomized Study is to confirm presence or absence of differences in gait mechanics in direct anterior and lateral approaches for total hip arthroplasty. and to compare the clinical outcomes of both approaches.

The main questions it aims to answer are:

if the anterior approach to the hip is faster recovery than lateral approach? if the anterior approach to the hip has better gait mechanics than lateral approach?

Participants will:

undergo one of the two approaches for total hip arthroplasty. All patients will be followed up at 2 weeks, 6 weeks, 3 months and 18 months. gait analysis will be done at 6wks, 3m, and 18months.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with primary osteoarthritis or osteonecrosis of the hip who consented for treatment with a total hip arthroplasty (THA) through an anterior or lateral approach.
  • Age between 20 - 60 years of age.
  • The participant had to be independent and physically active, which characterized as having the capacity to carry out daily tasks, ascend two flights of stairs, and able to walk for 15 minutes.

Exclusion criteria

  • Patients with bilateral hip affection.
  • Body mass index (BMI) greater than 40.
  • Diagnosis other than primary osteoarthritis or osteonecrosis.
  • Prior hip or spine surgery.
  • chronic uncontrolled comorbidities, psychological disorders.
  • American Society of Anaesthesiologists score (ASA) higher than 2
  • chronic neurological deficits that influence gait.
  • any limb length discrepancy more than 1 cm.
  • Any postoperative complication that will lead to delay in weight bearing.

Treatment and study plan

total hip replacement using lateral approach

Procedure

In the lateral approach partial detachment of the anterior one-third of the gluteus medius muscle.

total hip replacement using anterior approach

Procedure

the anterior approach using an internervous plane between the tensor fascia latae and the sartorius muscle.

gait analysis at 6wks, 3 months and 18 months

Device

gait analysis done in the gait lab at the mentioned postoperative periods

Primary outcomes

  1. surgery time

    Time frame: intraoperative time starting from skin incision to skin closure

    by ''Minute'' as the unit, no special description.

  2. hemoglobin drop

    Time frame: postoperative day one

    hemoglobin drop level between pre and postoperative.

  3. hospital stays

    Time frame: immediately after the procedure

    by ''Day'' as the unit, no special description. postoperative stay days from operation day to discharge day.

  4. pain score

    Time frame: 2 weeks 6 weeks 3 months 18 months

    using visual analogue scale (VAS) from 0-10 the more scale the worst the pain

  5. Harris hip score

    Time frame: 2 weeks 6 weeks 3 months 18 months

    for measuring hip function from 0-100 the more the score the better hip function

Secondary outcomes

  1. gait analysis

    Time frame: at 6 weeks, 3 months, 18 months

    A single experienced physical medicine specialist will perform the gait analysis in a gait lab. Three-dimensional kinematic and kinetic data will be collected using eight high-speed infrared cameras (Quality motion analysis system, oqus 1 cameras), which can capture 240 frames per second, two force plates (Advanced Mechanical Technology Incorporated, AMTI), and 26 ten-millimeter passive retroreflective markers fixed on the subject using a double-face tape in specific landmarks on the subject in accordance to the modified institute Orthopedic Rizzoli (IOR ) model for full body marker set.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty. A Prospective Randomized Study.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

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.