Back to resultsVariability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty
Primary Purpose
Osteoarthritis, Hip
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EOS X-Ray
Sponsored by
About this trial
This is an interventional health services research trial for Osteoarthritis, Hip
Eligibility 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.
Sites / Locations
- Mayo Clinic Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Pre-THA
Post-THA
Arm Description
Subjects will be receiving EOS imaging prior to Total Hip Arthoplasty
Subjects will be receiving EOS imaging after Total Hip Arthroplasty
Outcomes
Primary Outcome Measures
Change in pelvic incidence (PI)
Measured from EOS imaging and AP x-ray, reported in degrees
Change in symphysis to sacrococcygeal junction distance (PSCD)
Measured from EOS imaging and AP x-ray, reported in millimeters (mm)
Change in pelvic tilt (PT)
Measured from EOS imaging and AP x-ray, reported in degrees
Change in sacral slope (SS)
Measured from EOS imaging and AP x-ray, reported in degrees
Change in lumbar lordosis (LL)
Measured from EOS imaging and AP x-ray, reported in degrees
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05212090
Brief Title
Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty
Official Title
Study-Dependent Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-THA
Arm Type
Other
Arm Description
Subjects will be receiving EOS imaging prior to Total Hip Arthoplasty
Arm Title
Post-THA
Arm Type
Other
Arm Description
Subjects will be receiving EOS imaging after Total Hip Arthroplasty
Intervention Type
Diagnostic Test
Intervention Name(s)
EOS X-Ray
Intervention Description
Repeated AP Pelvis x-ray and Lateral Lumbar EOS x-ray
Primary Outcome Measure Information:
Title
Change in pelvic incidence (PI)
Description
Measured from EOS imaging and AP x-ray, reported in degrees
Time Frame
Baseline, 8 hours, 4 weeks
Title
Change in symphysis to sacrococcygeal junction distance (PSCD)
Description
Measured from EOS imaging and AP x-ray, reported in millimeters (mm)
Time Frame
Baseline, 8 hours, 4 weeks
Title
Change in pelvic tilt (PT)
Description
Measured from EOS imaging and AP x-ray, reported in degrees
Time Frame
Baseline, 8 hours, 4 weeks
Title
Change in sacral slope (SS)
Description
Measured from EOS imaging and AP x-ray, reported in degrees
Time Frame
Baseline, 8 hours, 4 weeks
Title
Change in lumbar lordosis (LL)
Description
Measured from EOS imaging and AP x-ray, reported in degrees
Time Frame
Baseline, 8 hours, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Abdel, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty
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