Influence of Femoral Head Size During Total Hip Arthroplasty on Gait

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip; Hip Arthritis; Gait, Frontal
• Intervention / Treatment: Procedure: Total hip replacement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Department of Othopedics and Rehabilitation, Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Standard size femoral head implant; Participants qualified to undergo total hip replacement who will receive standard femoral head size implant	Procedure: Total hip replacement; Total hip replacement in treatment of end-stage osteoarthritis
ACTIVE_COMPARATOR: Large size femoral head; Participants qualified to undergo total hip replacement who will receive large femoral head size implant	Procedure: Total hip replacement; Total hip replacement in treatment of end-stage osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of swing phase	Change from baseline part of swing phase time during gait, measured in percentage	at least 3,5 years after surgery
Time of stance phase	Change from baseline part of stance phase time during gait, measured in percentage	at least 3,5 years after surgery
Time of double-stance phase	Change from baseline part of double-stance phase time during gait, measured in percentage	at least 3,5 years after surgery
Stride length	Change from baseline length of stride during gait, measured in meters	at least 3,5 years after surgery
Cadence	Change from baseline number of strides per minute of walking	at least 3,5 years after surgery
Mean gait velocity	Change from baseline mean values of gait speed, measured in meters per second	at least 3,5 years after surgery
Range of maximal hip extension for both limbs during ending part of mid-stance phase	Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees	at least 3,5 years after surgery
Range of pelvic drop in frontal plane on the opposite site of the bearing limb	Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees	at least 3,5 years after surgery

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (ACTUAL): August 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: osteoarthritis; gait; biomechanics; hip; walk
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Gait Disorders, Neurologic
• Other Study ID Numbers: WarsawMU/Head

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
• IPD Sharing Access Criteria: The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No