Influence of Femoral Head Size During Total Hip Arthroplasty on Gait

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04521842
• Other study ID #: WarsawMU/Head
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2020

Study information

• Verified date: July 2020
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Frontal
• Hip Arthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Total hip replacement
Total hip replacement in treatment of end-stage osteoarthritis

Locations

Country	Name	City	State
Poland	Department of Othopedics and Rehabilitation, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of swing phase	Change from baseline part of swing phase time during gait, measured in percentage	at least 3,5 years after surgery
Primary	Time of stance phase	Change from baseline part of stance phase time during gait, measured in percentage	at least 3,5 years after surgery
Primary	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
Primary	Stride length	Change from baseline length of stride during gait, measured in meters	at least 3,5 years after surgery
Primary	Cadence	Change from baseline number of strides per minute of walking	at least 3,5 years after surgery
Primary	Mean gait velocity	Change from baseline mean values of gait speed, measured in meters per second	at least 3,5 years after surgery
Primary	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
Primary	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