Orthotic Management of CMC Osteoarthritis
The Effectiveness of 3D Printed, Low Temperature Thermoplastic, and Prefabricated Orthoses in the Management of Thumb Carpo-metacarpal Osteoarthritis: A Randomized, Controlled Trial.
1 other identifier
interventional
68
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 6, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedMarch 6, 2020
February 1, 2020
2 years
February 24, 2020
March 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Disabilities of the Arm Shoulder and Hand Questionnaire.
Patient reported outcome measure
Initial Visit, at 2 month visit, and at 1 year
Change in Pain
VAS scale for pain
Initial Visit, at 2 month visit, and at 1 year
4D CT Scan Changes
Effectiveness of Orthosis to stabilize CMC while pinching
At enrolment and again 2 months later
Secondary Outcomes (3)
Adherence
Measured at 2 month visit, with data downloaded biweekly
Orthosis Satisfaction Survey
At 2 month visit and at 1 year
Change in Pinch strength
Measured in CT scans at enrolment and at 2 month visit
Study Arms (2)
3D Orthosis
ACTIVE COMPARATORSee summary
Custom Thermoplastic Orthosis
ACTIVE COMPARATORSee summary
Interventions
Eligibility Criteria
You may qualify if:
- All patients with a diagnosis of CMC OA
You may not qualify if:
- Language barriers Cognitive barriers Previous thumb metacarpal fracture Advanced scapho-trapezial OA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Western University, Canadalead
- St. Joseph's Healthcare Foundationcollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2020
First Posted
March 6, 2020
Study Start
May 1, 2020
Primary Completion
May 1, 2022
Study Completion
May 31, 2022
Last Updated
March 6, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share