Correlation of Spinopelvic Movement With Lateral Radiographs

NCT ID: NCT05117229

Last Updated: 2023-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-01-19

Brief Summary

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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.

Detailed Description

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Conditions

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Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will have the MetaWear Sensors used on them
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

MetaWear Sensor

Intervention Type DEVICE

Sensor placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs will be taken

Interventions

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MetaWear Sensor

Sensor placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs will be taken

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Rafael J. Sierra, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael J Sierra, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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21-006428

Identifier Type: -

Identifier Source: org_study_id

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