Correlation of Spinopelvic Movement With Lateral Radiographs
Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05117229
Collaborator
(none)
40
1
1
12
3.3
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will have the MetaWear Sensors used on themAll participants will have the MetaWear Sensors used on them
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Correlation of Spinopelvic Movement With Lateral Radiographs to Assess Spine Motion Prior to Total Hip Arthroplasty
Actual Study Start Date
:
Dec 1, 2021
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Pelvic Tilt [Baseline]
as recorded by theMetaWear sensor reported in degrees
- Sacral Slope [Baseline]
as recorded by theMetaWear sensor reported in degrees
- Lumbar Lordosis [Baseline]
as recorded by theMetaWear sensor reported in degrees
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Rafael J Sierra, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Rafael J. Sierra, M.D.,
Principal Investigator,
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05117229
Other Study ID Numbers:
- 21-006428
First Posted:
Nov 11, 2021
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes