Influence of Femoral Head Size During Total Hip Arthroplasty on Gait

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoarthritis, Hip, Hip Arthritis, Gait, Frontal

Intervention / Treatment
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* Procedure: Total hip replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients qualified to undergo total hip arthroplasty due to the end-stage osteoarthritis will be randomly allocated to receive either standard femoral head size implants nor large ones. Pre- and postoperatively they will undergo gait analysis. To avoid risk of bias assessor will be blinded in terms of used implants in every participants case.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard size femoral head implant<br>Participants qualified to undergo total hip replacement who will receive standard femoral head size implant | Procedure: Total hip replacement<br>* Total hip replacement in treatment of end-stage osteoarthritis<br>|
| Active Comparator: Large size femoral head<br>Participants qualified to undergo total hip replacement who will receive large femoral head size implant | Procedure: Total hip replacement<br>* Total hip replacement in treatment of end-stage osteoarthritis<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip, osteoarthritis, gait, walk, biomechanics