Correlation of Spinopelvic Parameters and Acetabular Cup Orientation

NCT ID: NCT02598700

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-10-31

Brief 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. 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.

Conditions

Hip Osteoarthritis; Complications; Arthroplasty

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

-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.

Exclusion Criteria

• inflammatory arthritis
• neuromuscular disorders
• revision surgery

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thorsten Seyler, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Medical Plaza Page Road

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00066248

Identifier Type: -

Identifier Source: org_study_id