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Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05212090
Recruitment Status : Enrolling by invitation
First Posted : January 27, 2022
Last Update Posted : March 23, 2022
Sponsor:
Information provided by (Responsible Party):
Matthew P. Abdel, M.D., Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Diagnostic Test: EOS X-Ray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Study-Dependent Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Change in pelvic incidence (PI) [ Time Frame: Baseline, 8 hours, 4 weeks ]
    Measured from EOS imaging and AP x-ray, reported in degrees

  2. 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)

  3. Change in pelvic tilt (PT) [ Time Frame: Baseline, 8 hours, 4 weeks ]
    Measured from EOS imaging and AP x-ray, reported in degrees

  4. Change in sacral slope (SS) [ Time Frame: Baseline, 8 hours, 4 weeks ]
    Measured from EOS imaging and AP x-ray, reported in degrees

  5. Change in lumbar lordosis (LL) [ Time Frame: Baseline, 8 hours, 4 weeks ]
    Measured from EOS imaging and AP x-ray, reported in degrees



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05212090


Locations
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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Matthew Abdel, MD Mayo Clinic
Additional Information:
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Responsible Party: Matthew P. Abdel, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05212090    
Other Study ID Numbers: 21-011655
First Posted: January 27, 2022    Key Record Dates
Last Update Posted: March 23, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases