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Dynamic 4DCT to Examine Wrist Carpal Mechanics

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ClinicalTrials.gov Identifier: NCT04402502
Recruitment Status : Active, not recruiting
First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Western University, Canada

Brief Summary:
Osteoarthritis can develop after an injury like a broken bone. Problems with how the bones line up can lead to abnormal loading which will destroy the cartilage that covers and protects the bones. Once this happens, patients experience substantial pain and disability. Researchers and doctors use planar x-rays to evaluate joints; but these are not always precise and are limited to two dimensions. Three-dimensional (3D) computed tomography (CT) can be used to look at the joints of the wrist in three dimensions, but is limited to static frames. Symptoms arising from joint instability often occur when the wrist is moving and when it is performing a functional task (opening a jar). Four dimensional computed tomography (4DCT) can detect dynamics changes in the small structures of the wrist with high temporal and spatial resolution. This novel imaging techniques provides a movie of bones in the wrist, in 3D, while in the scanner. In this proposal, the investigator's will use 4DCT and look at how joint alignment of the distal radius effects the joints in the wrist, and investigate how it relates to patient's function, description of pain and the presence of Osteoarthritis 10 years following fracture. This imaging will drive safer clinical research and practice and will develop tools that predict the risk of developing arthritis that will help doctors determine when surgery is necessary to prevent arthritis of the hand and wrist, and pain and disability.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Ultrasound Imaging Not Applicable

Detailed Description:
A series of 60 participants (30 male: 30 female) with current distal radius fractures will be recruited. Clinical eligibility will include a unilateral DRF treated with closed reduction and casting. These measures will be assessed at baseline (<6 weeks following injury), 3- 6 months and 12 months following fracture. A second series of 80 participants (40 male: 40 female) who suffered a DRF ≥10 years previously will be recruited and tested. Exclusion criteria for these two cohorts will include presence of neurological disorders, rheumatoid arthritis or co-morbid health conditions that preclude completion of study measures. Twenty additional healthy participants will be recruited.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Healthy Population
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dynamic 4DCT to Examine the Effect of Mal-united Distal Radius Fractures on Carpal Contact Mechanics
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : September 26, 2021
Estimated Study Completion Date : February 2, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Population
Healthy Individuals with no presence of neurological disorders, rheumatoid arthritis or comorbid health conditions, and are not pregnant.
Device: Ultrasound Imaging
The participant will go to the Rheumatology clinic (St. Joseph's Hospital) and have 3D hand ultrasound performed on their hands.




Primary Outcome Measures :
  1. Hand Joint Spacing [ Time Frame: 3 years ]
    To measure joint spacing of the hand in a 3D ultrasound image



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • fluent in English, capacity to provide consent,
  • over the age of 18 years old, with no previous injury to either hand or wrist

Exclusion Criteria:

  • pregnancy and presence of neurological disorders, rheumatoid arthritis or comorbid health conditions that preclude completion of study measures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402502


Locations
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Canada, Ontario
St. Joseph's Hospital
London, Ontario, Canada
Sponsors and Collaborators
Western University, Canada
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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT04402502    
Other Study ID Numbers: 5147
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Western University, Canada:
3D Ultrasound Monitoring
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases