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Clinical Trials/NCT06538519
NCT06538519
Completed
Not Applicable

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

Ain Shams University1 site in 1 country34 target enrollmentJanuary 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
Ain Shams University
Enrollment
34
Locations
1
Primary Endpoint
hemoglobin drop
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2021
End Date
July 10, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

hemoglobin drop

Time Frame: postoperative day one

hemoglobin drop level between pre and postoperative.

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.

surgery time

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

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

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

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

  • gait analysis(at 6 weeks, 3 months, 18 months)

Study Sites (1)

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