Influence of Femoral Head Size During Total Hip Arthroplasty on Gait
Primary Purpose
Osteoarthritis, Hip, Hip Arthritis, Gait, Frontal
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Total hip replacement
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring osteoarthritis, hip, gait, walk, biomechanics
Eligibility Criteria
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
Sites / Locations
- Department of Othopedics and Rehabilitation, Medical University of Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Standard size femoral head implant
Large size femoral head
Arm Description
Participants qualified to undergo total hip replacement who will receive standard femoral head size implant
Participants qualified to undergo total hip replacement who will receive large femoral head size implant
Outcomes
Primary Outcome Measures
Time of swing phase
Change from baseline part of swing phase time during gait, measured in percentage
Time of stance phase
Change from baseline part of stance phase time during gait, measured in percentage
Time of double-stance phase
Change from baseline part of double-stance phase time during gait, measured in percentage
Stride length
Change from baseline length of stride during gait, measured in meters
Cadence
Change from baseline number of strides per minute of walking
Mean gait velocity
Change from baseline mean values of gait speed, measured in meters per second
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04521842
First Posted
August 10, 2020
Last Updated
October 5, 2021
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT04521842
Brief Title
Influence of Femoral Head Size During Total Hip Arthroplasty on Gait
Official Title
Influence of Large Head vs Standard Size During Total Hip Arthroplasty on Gait Analysis - Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Hip Arthritis, Gait, Frontal
Keywords
osteoarthritis, hip, gait, walk, biomechanics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard size femoral head implant
Arm Type
Placebo Comparator
Arm Description
Participants qualified to undergo total hip replacement who will receive standard femoral head size implant
Arm Title
Large size femoral head
Arm Type
Active Comparator
Arm Description
Participants qualified to undergo total hip replacement who will receive large femoral head size implant
Intervention Type
Procedure
Intervention Name(s)
Total hip replacement
Intervention Description
Total hip replacement in treatment of end-stage osteoarthritis
Primary Outcome Measure Information:
Title
Time of swing phase
Description
Change from baseline part of swing phase time during gait, measured in percentage
Time Frame
at least 3,5 years after surgery
Title
Time of stance phase
Description
Change from baseline part of stance phase time during gait, measured in percentage
Time Frame
at least 3,5 years after surgery
Title
Time of double-stance phase
Description
Change from baseline part of double-stance phase time during gait, measured in percentage
Time Frame
at least 3,5 years after surgery
Title
Stride length
Description
Change from baseline length of stride during gait, measured in meters
Time Frame
at least 3,5 years after surgery
Title
Cadence
Description
Change from baseline number of strides per minute of walking
Time Frame
at least 3,5 years after surgery
Title
Mean gait velocity
Description
Change from baseline mean values of gait speed, measured in meters per second
Time Frame
at least 3,5 years after surgery
Title
Range of maximal hip extension for both limbs during ending part of mid-stance phase
Description
Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees
Time Frame
at least 3,5 years after surgery
Title
Range of pelvic drop in frontal plane on the opposite site of the bearing limb
Description
Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees
Time Frame
at least 3,5 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartosz M. Maciąg, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Othopedics and Rehabilitation, Medical University of Warsaw
City
Warsaw
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Influence of Femoral Head Size During Total Hip Arthroplasty on Gait
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