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Completed

NCT Number: NCT04640740

Isokinetic Performance and Function After Total Hip Arthroplasty

There are ongoing debates on the effects of the surgical approach on outcome after total hip arthroplasty. It was hypothesized that with the anterolateral approach, trauma to the abductor arm can be occured and related detrimental effects can diminish the post-operative outcomes. In this first randomized controlled trial in the literature on this subject, isokinetic performance and patient-reported functional outcomes were evaluated in patients undergoing total hip arthroplasty. with a posterior approach (PA) and a anterolateral approach (ALA), at 6 and 12 months postoperatively.

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Key information

Conditions

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

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Teaching and Research Hospital

Ankara, 06010, Turkey (Türkiye)

About this study

Patients undergoing total hip arthroplasty are randomized to posterior approach (PA) and anterolateral approach (ALA) groups. The patients are evaluated preoperatively and at 6 and 12 months postoperatively, with flexion, extension and abduction strength measurements and the Harris Hip Score (HHS). The physiatrist performing isokinetic tests and the patients are blinded to the study groups.All data are calculated as mean and standard deviation values. The Student's t-test is used for statistical analysis of the patient data. Statistical calculations are performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients aged 55 to 80 years unilateral primary hip osteoarthritis -

Exclusion criteria

bilateral osteoarthritis inflammatory arthritis post-traumatic osteoarthritis previous hip surgery neuromuscular diseases

Treatment and study plan

hip arthroplasty

Procedure

two different approaches of total hip arthroplasty

Primary outcomes

  1. isokinetic test

    Time frame: Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results

    isokinetic test during flexion, extension and abduction of the hip

Secondary outcomes

  1. Harris Hip Score

    Time frame: Change from preoperativeHarris Hip Score results at 6th months and 12th months iHarris Hip Score results

    Functional score of the hip. Harris Hip Score: 100-90: Excellent 89-80:Good 79-70:Fair below 70:Poor

Sponsors and collaborators

Lead sponsor

Gulhane Training and Research Hospital

Other Gov

Registry information

Official study title

Isokinetic Performance and Function Are Similar 12 Months After Total Hip Arthroplasty Applied With a Posterior or Anterolateral Approach: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2020
Registry last updated
Nov 23, 2020

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.

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