Correlation of Spinopelvic Movement With Lateral Radiographs

Correlation of Spinopelvic Movement With Lateral Radiographs to Assess Spine Motion Prior to Total Hip Arthroplasty

The purpose of this research is to compare a novel pelvic MetaWear sensor that looks at spine and pelvic movements when taking lateral sit-to-stand radiographs.

Study Overview

• Status: Completed
• Conditions: Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's
• Intervention / Treatment: Device: MetaWear Sensor

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to provide informed consent.
• Hip pathology: 20 presenting for total hip arthroplasty, 20 presenting for joint preservation procedures.

Exclusion Criteria:

- Patients with lumbosacral hardware, contralateral THA, or DJD in the contralateral hip.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MetaWear Sensor on radiograph; subjects being considered for surgical orthopedic surgery will have a MetaWear sensor added to their standard of care lateral sit to stand radiograph	Device: MetaWear Sensor; Sensor placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs will be taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Tilt (PT)	PT is a position dependent parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and vertical axis. As recorded by theMetaWear sensor reported in degrees.	Baseline
Sacral Slope (SS)	Sacral slope (SS) is a position-dependent parameter defined as the angle between a line parallel to the sacral end plate and a horizontal line. As recorded by theMetaWear sensor reported in degrees.	Baseline
Pelvic Incidence (PI)	PI is defined as the angle between a line perpendicular to the sacral plate at its midpoint and a line connecting the same point to the center of the bicoxofemoral axis. As recorded by theMetaWear sensor reported in degrees.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Rafael J Sierra, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-006428

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes