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Orthotic Management of CMC Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297943
Recruitment Status : Not yet recruiting
First Posted : March 6, 2020
Last Update Posted : March 6, 2020
Sponsor:
Collaborators:
St. Joseph's Healthcare Foundation
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Western University, Canada

Brief Summary:
This study will investigate the effectiveness of 3D printed splints for the treatment of thumb osteoarthritis (CMC OA). Currently, these splints are made by Occupational Therapists and Physical Therapists out of low temperature plastic, and formed on the patient's hand. 3D printed splints involve taking a photographic scan of the hand and creating a digital file of the splint. This is then printed and fit on the patient. This study will compare the effectiveness of these methods of splint fabrication. Our outcomes will include measurements of pain relief, adherence, patient satisfaction, muscle contraction and CT imaging during pinch tasks to measure the ability of these splint types to support the CMC joint.

Condition or disease Intervention/treatment Phase
Arthritis Wrist Device: Orthosis fabrication Device: Thermal Sensor Monitoring of Orthosis Use Diagnostic Test: 4D CT Scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of 3D Printed, Low Temperature Thermoplastic, and Prefabricated Orthoses in the Management of Thumb Carpo-metacarpal Osteoarthritis: A Randomized, Controlled Trial.
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 3D Orthosis
See summary
Device: Orthosis fabrication
see summary

Device: Thermal Sensor Monitoring of Orthosis Use
see summary

Diagnostic Test: 4D CT Scan
see summary

Active Comparator: Custom Thermoplastic Orthosis
See summary
Device: Orthosis fabrication
see summary

Device: Thermal Sensor Monitoring of Orthosis Use
see summary

Diagnostic Test: 4D CT Scan
see summary




Primary Outcome Measures :
  1. Change in Disabilities of the Arm Shoulder and Hand Questionnaire. [ Time Frame: Initial Visit, at 2 month visit, and at 1 year ]
    Patient reported outcome measure

  2. Change in Pain [ Time Frame: Initial Visit, at 2 month visit, and at 1 year ]
    VAS scale for pain

  3. 4D CT Scan Changes [ Time Frame: At enrolment and again 2 months later ]
    Effectiveness of Orthosis to stabilize CMC while pinching


Secondary Outcome Measures :
  1. Adherence [ Time Frame: Measured at 2 month visit, with data downloaded biweekly ]
    Measured via log book and temperature sensors

  2. Orthosis Satisfaction Survey [ Time Frame: At 2 month visit and at 1 year ]
    Assessment of participants satisfaction with orthosis

  3. Change in Pinch strength [ Time Frame: Measured in CT scans at enrolment and at 2 month visit ]
    Pinch gauge measurements



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:   No
Criteria

Inclusion Criteria:

All patients with a diagnosis of CMC OA

Exclusion Criteria:

Language barriers Cognitive barriers Previous thumb metacarpal fracture Advanced scapho-trapezial OA

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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT04297943    
Other Study ID Numbers: 115441
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
arthritis
orthotics
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases