Correlation of Spinopelvic Parameters and Acetabular Cup Orientation

NCT02598700 | Completed

• 1 other identifier: Pro00066248
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis; Complications; Arthroplasty

Keywords

total hip arthroplasty; imaging; arthritis; surgical technique

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 year

Secondary Outcomes (5)

• Presence of lumbar pathology

  1 year

• Previous lumbar surgery - fusion type

  1 year

• Previous lumbar surgery - length of fusion

  1 year

• Total hip arthroplasty dislocation

  1 year

• Other total hip arthroplasty complication

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• inflammatory arthritis
• neuromuscular disorders
• revision surgery

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medical Plaza Page Road

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thorsten Seyler, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 6, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

US (1)