NCT05212090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

January 26, 2022

Last Update Submit

March 13, 2025

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (5)

  • Change in pelvic incidence (PI)

    Measured from EOS imaging and AP x-ray, reported in degrees

    Baseline, 8 hours, 4 weeks

  • Change in symphysis to sacrococcygeal junction distance (PSCD)

    Measured from EOS imaging and AP x-ray, reported in millimeters (mm)

    Baseline, 8 hours, 4 weeks

  • Change in pelvic tilt (PT)

    Measured from EOS imaging and AP x-ray, reported in degrees

    Baseline, 8 hours, 4 weeks

  • Change in sacral slope (SS)

    Measured from EOS imaging and AP x-ray, reported in degrees

    Baseline, 8 hours, 4 weeks

  • Change in lumbar lordosis (LL)

    Measured from EOS imaging and AP x-ray, reported in degrees

    Baseline, 8 hours, 4 weeks

Study Arms (2)

Pre-THA

OTHER

Subjects will be receiving EOS imaging prior to Total Hip Arthroplasty (THA)

Diagnostic Test: EOS X-Ray

Post-THA

OTHER

Subjects will be receiving EOS imaging after Total Hip Arthroplasty (THA)

Diagnostic Test: EOS X-Ray

Interventions

EOS X-RayDIAGNOSTIC_TEST

Repeated Anteroposterior (AP) Pelvis x-ray and Lateral Lumbar EOS x-ray

Post-THAPre-THA

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide informed consent.
  • 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.

You may not qualify if:

  • \- Patients with lumbosacral hardware, contralateral THA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Matthew Abdel, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2022

First Posted

January 27, 2022

Study Start

February 1, 2022

Primary Completion

March 12, 2025

Study Completion

March 12, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

US(1)