Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty

January 25, 2024 updated by: Matthew P. Abdel, M.D., Mayo Clinic

Study-Dependent Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty

This research is being conducted to assess measurement correlations on different X-ray views on patients who have undergone or will undergo hip reconstruction surgery.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to provide informed consent.
  • 40 patients: 20 preoperative THA, 20 postoperative THA;
  • Sex: 20 men, 20 women;
  • Age: 20 patients ≥ 70 years, 10 patients 50-70 years, 10 patients 18-50 years.

Exclusion Criteria:

- Patients with lumbosacral hardware, contralateral THA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pre-THA
Subjects will be receiving EOS imaging prior to Total Hip Arthoplasty
Diagnostic test: EOS X-Ray
Repeated AP Pelvis x-ray and Lateral Lumbar EOS x-ray
Other: Post-THA
Subjects will be receiving EOS imaging after Total Hip Arthroplasty
Diagnostic test: EOS X-Ray
Repeated AP Pelvis x-ray and Lateral Lumbar EOS x-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pelvic incidence (PI)
Time Frame: Baseline, 8 hours, 4 weeks
Measured from EOS imaging and AP x-ray, reported in degrees
Baseline, 8 hours, 4 weeks
Change in symphysis to sacrococcygeal junction distance (PSCD)
Time Frame: Baseline, 8 hours, 4 weeks
Measured from EOS imaging and AP x-ray, reported in millimeters (mm)
Baseline, 8 hours, 4 weeks
Change in pelvic tilt (PT)
Time Frame: Baseline, 8 hours, 4 weeks
Measured from EOS imaging and AP x-ray, reported in degrees
Baseline, 8 hours, 4 weeks
Change in sacral slope (SS)
Time Frame: Baseline, 8 hours, 4 weeks
Measured from EOS imaging and AP x-ray, reported in degrees
Baseline, 8 hours, 4 weeks
Change in lumbar lordosis (LL)
Time Frame: Baseline, 8 hours, 4 weeks
Measured from EOS imaging and AP x-ray, reported in degrees
Baseline, 8 hours, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Matthew Abdel, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-011655

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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