A Study to Evaluate 4DCT Controls

NCT ID: NCT04736537

Last Updated: 2024-05-02

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-04

Study Completion Date

2023-04-06

Brief Summary

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The purpose of this study is to use CT motion pictures (4DCT) to visualize and record how much space there is between certain wrist joint bones, both without any resistance and with light resistance to the movement, during a single scanning visit.

Detailed Description

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Conditions

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Wrist Ligament and Bone Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Controls

Group Type EXPERIMENTAL

4DCT

Intervention Type DEVICE

CT imaging conceptually similar to time-lapse photography.

Interventions

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4DCT

CT imaging conceptually similar to time-lapse photography.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 and ≤ 60 years.
* Control subjects without any history of wrist injury or disease.

Exclusion Criteria

* Previously-diagnosed rheumatological conditions or connective tissue diseases;
* Inability to be appropriately positioned in the scanner for the imaging;
* Congenital malformations of the wrist or forearm;
* Diagnosed wrist osteoarthritis
* Age under 18 or over 60.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kristin Zhao, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin D. Zhao, Ph.D.

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 and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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R01AR071338

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-007668

Identifier Type: -

Identifier Source: org_study_id

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