Osteoarthritis, HipNCT04521842
Influence of Femoral Head Size During Total Hip Arthroplasty on Gait
A study testing Total hip replacement in people with Osteoarthritis, Hip and Hip Arthritis, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteoarthritis, Hip, Hip Arthritis, Gait, Frontal
- What is being tested?
- Total hip replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI <35
- Ability to walk for 10 meters
- 60-80 years of age
- Bilateral THR
Who cannot join
- Revision surgeries before and after THR
- Any other lower limbs surgeries
- Secondary OA
- Neurological disorders
- Cardiac disorders
- Severly impaired balance
- Severe dizziness
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Hip, Hip Arthritis, Gait, Frontal
- Being tested
- Total hip replacement
- Keywords
- osteoarthritis, hip, gait, walk, biomechanics
- Medical subject headings
- Osteoarthritis, Hip, Gait Disorders, Neurologic, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacementProcedure or surgery
Total hip replacement in treatment of end-stage osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Standard size femoral head implant | Placebo comparator | Participants qualified to undergo total hip replacement who will receive standard femoral head size implant Receives: Procedure: Total hip replacement |
| Large size femoral head | Active comparator | Participants qualified to undergo total hip replacement who will receive large femoral head size implant Receives: Procedure: Total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of swing phase
Change from baseline part of swing phase time during gait, measured in percentage
Measured: at least 3,5 years after surgery
Time of stance phase
Change from baseline part of stance phase time during gait, measured in percentage
Measured: 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
Measured: at least 3,5 years after surgery
Stride length
Change from baseline length of stride during gait, measured in meters
Measured: at least 3,5 years after surgery
Cadence
Change from baseline number of strides per minute of walking
Measured: at least 3,5 years after surgery
Mean gait velocity
Change from baseline mean values of gait speed, measured in meters per second
Measured: 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
Measured: 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
Measured: at least 3,5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study startJan 2016
- Primary completionJul 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartosz M. Maciąg, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521842
- Sponsor's protocol ID
- WarsawMU/Head
- Status last verified
- Jul 2020
- First submitted
- 10 Aug 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Large Head vs Standard Size During Total Hip Arthroplasty on Gait Analysis - Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04521842
- Acronym / sponsor ID
- WarsawMU/Head
- Conditions
- Osteoarthritis, Hip, Hip Arthritis, Gait, Frontal
- Keywords
- osteoarthritis, hip, gait, walk, biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard size femoral head implant | Placebo comparator | Procedure: Total hip replacementParticipants qualified to undergo total hip replacement who will receive standard femoral head size implant |
| Large size femoral head | Active comparator | Procedure: Total hip replacementParticipants qualified to undergo total hip replacement who will receive large femoral head size implant |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI <35
- Ability to walk for 10 meters
- 60-80 years of age
- Bilateral THR
Key exclusion criteria (7 listed)
- Revision surgeries before and after THR
- Any other lower limbs surgeries
- Secondary OA
- Neurological disorders
- Cardiac disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip replacementTotal hip replacement in treatment of end-stage osteoarthritis | Procedure or surgery | Large size femoral head, Standard size femoral head implant |
Primary outcome
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
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
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
Stride length
Time frame: at least 3,5 years after surgery
Change from baseline length of stride during gait, measured in meters
Cadence
Time frame: at least 3,5 years after surgery
Change from baseline number of strides per minute of walking
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
Related trials for Osteoarthritis, Hip
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bartosz M. Maciąg, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip replacement in people with Osteoarthritis, Hip and Hip Arthritis, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of swing phase (time frame: at least 3,5 years after surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.