Skip to main content
OpenTrials
Completed

NCT Number: NCT04521842

Influence of Femoral Head Size During Total Hip Arthroplasty on Gait

Total hip replacement (THR) is being considered as one of the most effective medical procedures. Since its introduction, there was a worldwide debate over proper implant selection in terms of size, bearing type and shape. The diameter of used femoral heads components grew throughout the years - from 22 mm in the 1960s to 32 mm in the 2000s, which is the most commonly used size nowadays. In recent years there was a visible use of large femoral heads (>=36mm) in several registers. In the USA there was a significant grow in use of this heads rising from 1% in early 200s to even 58% in 2009. There is a strong evidence data and many researchers concerning range of movement, risk of dislocation, functional results, pain and prosthesis wear depending of femoral head size.

In terms of gait characteristics there are several deviations reported concerning both patients with hip osteoarthritis (OA) and following THR. There is a lack of literature concerning influence of used implants on gait parameters and whether this goal of the surgery can be achieved.

The aim of this study was to assess potential differences of lower limb biomechanics during gait in patients following total hip replacement surgery depending on femoral head diameter and compare them to the normal gait of healthy volunteers. As a secondary outcome authors wanted to inspect correlation between gait parameters and patient-reported outcome.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Hip Arthritis Gait Disorders, Neurologic Gait, Frontal Hip Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Poland

About this study

Total hip replacement (THR) is being considered as one of the most effective medical procedures. Since its introduction, there was a worldwide debate over proper implant selection in terms of size, bearing type and shape. The diameter of used femoral heads components grew throughout the years - from 22 mm in the 1960s to 32 mm in the 2000s, which is the most commonly used size nowadays. In recent years there was a visible use of large femoral heads (>=36mm) in several registers. In the USA there was a significant grow in use of this heads rising from 1% in early 200s to even 58% in 2009. There is a strong evidence data and many researchers concerning range of movement, risk of dislocation, functional results, pain and prosthesis wear depending of femoral head size.

In terms of gait characteristics there are several deviations reported concerning both patients with hip osteoarthritis (OA) and following THR. It is well-proven that those with hip OA have reduced stride length and reduced cadence, reduced gait velocity, and reduced joint excursion. Patients after THR walk with lower hip-abduction moments, sagittal-plane range of motion. It is believed that it might be a consequence of pain-avoidance mechanism developed as an adaptation for joint disease, which is still present after the surgery. What is more, there are publications, which underline that lower limb biomechanics during gait do not return to normal following THR.

However there is a lack of literature concerning influence of used implants on gait parameters and whether this goal of the surgery can be achieved.

According to authors best knowledge this study is the first to ever describe potential differences in gait parameters between THR performed with standard femoral heads (28-32mm) and large ones (>=36mm).

Aim of the study The aim of this study was to assess potential differences of lower limb biomechanics during gait in patients following total hip replacement surgery depending on femoral head diameter and compare them to the normal gait of healthy volunteers. As a secondary outcome authors wanted to inspect correlation between gait parameters and patient-reported outcome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI <35
  • Ability to walk for 10 meters
  • 60-80 years of age
  • Bilateral THR

Exclusion criteria

  • Revision surgeries before and after THR
  • Any other lower limbs surgeries
  • Secondary OA
  • Neurological disorders
  • Cardiac disorders
  • Severly impaired balance
  • Severe dizziness

Treatment and study plan

Total hip replacement

Procedure

Total hip replacement in treatment of end-stage osteoarthritis

Primary outcomes

  1. Time of swing phase

    Time frame: at least 3,5 years after surgery

    Change from baseline part of swing phase time during gait, measured in percentage

  2. Time of stance phase

    Time frame: at least 3,5 years after surgery

    Change from baseline part of stance phase time during gait, measured in percentage

  3. Time of double-stance phase

    Time frame: at least 3,5 years after surgery

    Change from baseline part of double-stance phase time during gait, measured in percentage

  4. Stride length

    Time frame: at least 3,5 years after surgery

    Change from baseline length of stride during gait, measured in meters

  5. Cadence

    Time frame: at least 3,5 years after surgery

    Change from baseline number of strides per minute of walking

  6. Mean gait velocity

    Time frame: at least 3,5 years after surgery

    Change from baseline mean values of gait speed, measured in meters per second

  7. Range of maximal hip extension for both limbs during ending part of mid-stance phase

    Time frame: at least 3,5 years after surgery

    Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees

  8. Range of pelvic drop in frontal plane on the opposite site of the bearing limb

    Time frame: at least 3,5 years after surgery

    Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Influence of Large Head vs Standard Size During Total Hip Arthroplasty on Gait Analysis - Prospective Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2020
Registry last updated
Oct 14, 2021

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.