Hip OsteoarthritisNCT02598700
Correlation of Spinopelvic Parameters and Acetabular Cup Orientation
An observational study of Hip Osteoarthritis and Complications; Arthroplasty, run by Duke University at 1 site in United States.
Trial summary
In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's safe zone and functional anteversion are often used to assess appropriate orientation. However, these approaches do not consider the effect of the spinopelvic chain and lumbar mobility when in the seated position. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis, Complications; Arthroplasty
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Oct 2018
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients who have undergone THA with the appropriate pre-operative CT for planning and those who are candidates for primary THA for osteoarthritis will be contacted for recruitment. Those with inflammatory arthritides or neuromuscular disorders will not be eligible for the study. Women of childbearing age will also be excluded from this study. Base on the power analysis below, the investigators anticipate eighty-four (84) patients will be enrolled into this study.
Who may be able to join
- -All patients who have undergone THA with the appropriate pre-operative CT for planning and those who are candidates for primary THA for osteoarthritis will be contacted for recruitment.
Who cannot join
- inflammatory arthritis
- neuromuscular disorders
- revision surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Medical Plaza Page Road
Durham, North Carolina, 27703
About this study
Official title: Measurement and Quantitative Correlation of Spinopelvic Parameters and Acetabular Cup Orientation Between Standing and Sitting to Define a Better Functional Anteversion Safe Zone in Total Hip Arthroplasty
In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's safe zone and functional anteversion are often used to assess appropriate orientation. However, these approaches do not consider the effect of the spinopelvic chain and lumbar mobility when in the seated position. This study will measure functional anteversion when standing and sitting with patient-specific computer models and define a quantitative relationship between the change in functional anteversion and spinopelvic parameters. This will challenge the historical paradigm of the safe zone and provide a tool to define anteversion based on a patient's mechanics and reduce risk of dislocation.
Read the detailed description
In total hip arthroplasty (THA), incorrect cup orientation markedly increases the risk of dislocation, wear, and impingement. The primary method of cup placement is based on the surgeon's interpretation of orientation within a "safe zone" defined by Lewinnek almost 40 years ago. This approach has undergone little change despite consistent dislocation rates and a large proportion of dislocations occurring in patients with cups within the safe zone. One reason for this may be that it does not account for a patient's natural pelvic posture, which affects the functional cup anteversion. Some modern techniques of cup placement assess a functional anteversion based on supine and others on standing orientation. However, these methods do not account for lumbar mobility and the effects on spinopelvic mechanics when in the seated position, the most common position in which dislocation occurs. The investigators have shown that patients with lumbar fusion have a higher rate of THA dislocation. This risk also correlated with length of fusion construct. This suggests that decreased lumbar mobility, whether a result of arthrodesis, disease or age related degeneration, may play an important role in the risk of THA dislocation. Some studies have measured change in pelvic orientation and cup anteversion between sitting and standing. Others have used modeling to estimate change in functional anteversion based on pelvic tilt. Presently, however, there are no studies that have investigated the quantitative relationship, in vivo, between patient-specific changes in spinopelvic parameters and cup anteversion between sitting and standing. Within this exploration, identification of an appropriate safe zone in individuals with mobility restrictions of the lumbar spine is not possible.
The investigators will test the hypothesis by addressing the aims presented below. These aims will be approached by directly measuring the spinopelvic parameters on standing and seated radiographs in 100 patients who have undergone primary THA. Computer models of cups and pelvises generated from patient-specific pelvis CTs will be manipulated based on the measured changes in pelvic alignment. The change in functional cup anteversion will then be directly measured from each patient's model.
Specific Aim #1: To quantify the relationship between the change in pelvic tilt and functional acetabular cup anteversion between the standing and sitting positions in patients who have undergone primary THA. The investigators hypothesize that there will be a directly proportional relationship between the increase in pelvic tilt and increase in functional anteversion. The investigators anticipate that Aim #1 will identify the importance of functional anteversion in the seated position and support its consideration when defining a patient-specific cup safe zone. This data will serve as the foundation for development of a clinical tool used in pre-operative planning and post- operative rehabilitation that accounts for spinopelvic mechanics to maintain safe cup orientation when in the vulnerable seated position.
Specific Aim #2: To quantify the relationship between the change in lumbar lordosis and functional acetabular cup anteversion between the standing and sitting positions in patients who have undergone primary THA. The investigators hypothesize that there will be a directly proportional relationship between the decrease in lumbar lordosis and increase in functional anteversion and that patients with history of lumbar immobility will have decreased change in functional anteversion. The data obtained in Aim #2 can be used to identify those at increased risk of dislocation. It will also provide insight into, and a basis for further study of, the relationship between seated functional anteversion and specific etiologies of lumbar immobility (spinal fusion, ankylosing spondylitis, flat back syndrome, degenerative changes, etc.) that may affect THA dislocation.
The overall objective of this study is to define a clinically relevant and applicable quantitative correlation between the change in spinopelvic parameters and change in functional anteversion between the standing and seated positions and challenge the historical safe zone paradigm. The central hypothesis is that the change spinopelvic mobility correlates with the change in functional anteversion. The investigators believe that this quantitative relationship will provide the clinician a tool to identify at-risk THA candidates and make appropriate patient-specific modifications to cup anteversion and post-operative rehabilitation.
- Conditions
- Hip Osteoarthritis, Complications; Arthroplasty
- Keywords
- total hip arthroplasty, imaging, arthritis, surgical technique
- Medical subject headings
- Osteoarthritis, Hip, Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative correlation between change functional anteversion and change in pelvic tilt using patient-specific measurements and computer models.
A quantitative relationship will be generated correlating change in cup anteversion (change in degrees) to change in pelvic tilt (change in degrees) at given inclinations (degrees) as simulated in the model. Statistical analysis will then be performed. Significance of changes between standing and sitting in pelvic tilt and cup anteversion will be assessed with t-test or non-parametric equivalent if appropriate with significance p<0.05. The effect of change in pelvic tilt on change in functional anteversion will be tested using a two-tailed Pearson product moment.
Measured: 1 year
Quantitative correlation between change functional anteversion and change in lumbar lordosis using patient-specific measurements and computer models.
A quantitative relationship will be generated correlating change in cup anteversion (change in degrees) to change in lumbar lordosis (change in degrees). Statistical analysis will then be performed. Significance of changes between standing and sitting in lumbar lordosis and cup anteversion will be assessed with t-test or non-parametric equivalent if appropriate with significance p<0.05. The effect of change in lumbar lordosis on change in functional anteversion will be tested using a two-tailed Pearson product moment.
Measured: 1 year
Secondary outcomes (5)
Presence of lumbar pathology
degenerative disc disease, posterior degenerative disease, osteophytosis, ankylosing spondylitis, scoliosis, or flat back syndrome
Measured: 1 year
Previous lumbar surgery - fusion type
posterior, anterior, or combined
Measured: 1 year
Previous lumbar surgery - length of fusion
number of fusion levels
Measured: 1 year
Total hip arthroplasty dislocation
presence of dislocation
Measured: 1 year
Other total hip arthroplasty complication
loosening, fracture, or infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thorsten Seyler, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598700
- Sponsor's protocol ID
- Pro00066248
- Status last verified
- Jun 2019
- First submitted
- 5 Nov 2015
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Quantitative Correlation of Spinopelvic Parameters and Acetabular Cup Orientation Between Standing and Sitting to Define a Better Functional Anteversion Safe Zone in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02598700
- Acronym / sponsor ID
- Pro00066248
- Conditions
- Hip Osteoarthritis, Complications; Arthroplasty
- Keywords
- total hip arthroplasty, imaging, arthritis, surgical technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 6 Nov 2015 (estimated)
- 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.
In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's safe zone and functional anteversion are often used to assess appropriate orientation. However, these approaches do not consider the effect of the spinopelvic chain and lumbar mobility when in the seated position. This study will measure functional anteversion when standing and sitting with patient-specific computer models and define a quantitative relationship between the change in functional anteversion and spinopelvic parameters. This will challenge the historical paradigm of the safe zone and provide a tool to define anteversion based on a patient's mechanics and reduce risk of dislocation.
Detailed description
In total hip arthroplasty (THA), incorrect cup orientation markedly increases the risk of dislocation, wear, and impingement. The primary method of cup placement is based on the surgeon's interpretation of orientation within a "safe zone" defined by Lewinnek almost 40 years ago. This approach has undergone little change despite consistent dislocation rates and a large proportion of dislocations occurring in patients with cups within the safe zone. One reason for this may be that it does not account for a patient's natural pelvic posture, which affects the functional cup anteversion. Some modern techniques of cup placement assess a functional anteversion based on supine and others on standing orientation. However, these methods do not account for lumbar mobility and the effects on spinopelvic mechanics when in the seated position, the most common position in which dislocation occurs. The investigators have shown that patients with lumbar fusion have a higher rate of THA dislocation. This risk also correlated with length of fusion construct. This suggests that decreased lumbar mobility, whether a result of arthrodesis, disease or age related degeneration, may play an important role in the risk of THA dislocation. Some studies have measured change in pelvic orientation and cup anteversion between sitting and standing. Others have used modeling to estimate change in functional anteversion based on pelvic tilt. Presently, however, there are no studies that have investigated the quantitative relationship, in vivo, between patient-specific changes in spinopelvic parameters and cup anteversion between sitting and standing. Within this exploration, identification of an appropriate safe zone in individuals with mobility restrictions of the lumbar spine is not possible.
The investigators will test the hypothesis by addressing the aims presented below. These aims will be approached by directly measuring the spinopelvic parameters on standing and seated radiographs in 100 patients who have undergone primary THA. Computer models of cups and pelvises generated from patient-specific pelvis CTs will be manipulated based on the measured changes in pelvic alignment. The change in functional cup anteversion will then be directly measured from each patient's model.
Specific Aim #1: To quantify the relationship between the change in pelvic tilt and functional acetabular cup anteversion between the standing and sitting positions in patients who have undergone primary THA. The investigators hypothesize that there will be a directly proportional relationship between the increase in pelvic tilt and increase in functional anteversion. The investigators anticipate that Aim #1 will identify the importance of functional anteversion in the seated position and support its consideration when defining a patient-specific cup safe zone. This data will serve as the foundation for development of a clinical tool used in pre-operative planning and post- operative rehabilitation that accounts for spinopelvic mechanics to maintain safe cup orientation when in the vulnerable seated position.
Specific Aim #2: To quantify the relationship between the change in lumbar lordosis and functional acetabular cup anteversion between the standing and sitting positions in patients who have undergone primary THA. The investigators hypothesize that there will be a directly proportional relationship between the decrease in lumbar lordosis and increase in functional anteversion and that patients with history of lumbar immobility will have decreased change in functional anteversion. The data obtained in Aim #2 can be used to identify those at increased risk of dislocation. It will also provide insight into, and a basis for further study of, the relationship between seated functional anteversion and specific etiologies of lumbar immobility (spinal fusion, ankylosing spondylitis, flat back syndrome, degenerative changes, etc.) that may affect THA dislocation.
The overall objective of this study is to define a clinically relevant and applicable quantitative correlation between the change in spinopelvic parameters and change in functional anteversion between the standing and seated positions and challenge the historical safe zone paradigm. The central hypothesis is that the change spinopelvic mobility correlates with the change in functional anteversion. The investigators believe that this quantitative relationship will provide the clinician a tool to identify at-risk THA candidates and make appropriate patient-specific modifications to cup anteversion and post-operative rehabilitation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who have undergone THA with the appropriate pre-operative CT for planning and those who are candidates for primary THA for osteoarthritis will be contacted for recruitment. Those with inflammatory arthritides or neuromuscular disorders will not be eligible for the study. Women of childbearing age will also be excluded from this study. Base on the power analysis below, the investigators anticipate eighty-four (84) patients will be enrolled into this study.
Key inclusion criteria (1 listed)
- -All patients who have undergone THA with the appropriate pre-operative CT for planning and those who are candidates for primary THA for osteoarthritis will be contacted for recruitment.
Key exclusion criteria (3 listed)
- inflammatory arthritis
- neuromuscular disorders
- revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative correlation between change functional anteversion and change in pelvic tilt using patient-specific measurements and computer models.
Time frame: 1 year
A quantitative relationship will be generated correlating change in cup anteversion (change in degrees) to change in pelvic tilt (change in degrees) at given inclinations (degrees) as simulated in the model. Statistical analysis will then be performed. Significance of changes between standing and sitting in pelvic tilt and cup anteversion will be assessed with t-test or non-parametric equivalent if appropriate with significance p<0.05. The effect of change in pelvic tilt on change in functional anteversion will be tested using a two-tailed Pearson product moment.
Quantitative correlation between change functional anteversion and change in lumbar lordosis using patient-specific measurements and computer models.
Time frame: 1 year
A quantitative relationship will be generated correlating change in cup anteversion (change in degrees) to change in lumbar lordosis (change in degrees). Statistical analysis will then be performed. Significance of changes between standing and sitting in lumbar lordosis and cup anteversion will be assessed with t-test or non-parametric equivalent if appropriate with significance p<0.05. The effect of change in lumbar lordosis on change in functional anteversion will be tested using a two-tailed Pearson product moment.
5 secondary outcomes
Presence of lumbar pathology
Time frame: 1 year
Previous lumbar surgery - fusion type
Time frame: 1 year
Previous lumbar surgery - length of fusion
Time frame: 1 year
Total hip arthroplasty dislocation
Time frame: 1 year
Other total hip arthroplasty complication
Time frame: 1 year
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 7 Jun 2019.
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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.
Thorsten Seyler, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis and Complications; Arthroplasty, run by Duke University at 1 site in United States.
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 1 inclusion and 3 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 7 Jun 2019. 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 United States. 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. 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?
Quantitative correlation between change functional anteversion and change in pelvic tilt using patient-specific measurements and computer models. (time frame: 1 year). The study lists 2 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 7 Jun 2019.