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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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.

  1. 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

  2. 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)
  1. Presence of lumbar pathology

    degenerative disc disease, posterior degenerative disease, osteophytosis, ankylosing spondylitis, scoliosis, or flat back syndrome

    Measured: 1 year

  2. Previous lumbar surgery - fusion type

    posterior, anterior, or combined

    Measured: 1 year

  3. Previous lumbar surgery - length of fusion

    number of fusion levels

    Measured: 1 year

  4. Total hip arthroplasty dislocation

    presence of dislocation

    Measured: 1 year

  5. 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.

  1. First posted6 Nov 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionOct 2018
  4. Study completionOct 2018

Resources

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)
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

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.

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