Orthotic Management of CMC Osteoarthritis
Primary Purpose
Arthritis Wrist
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orthosis fabrication
Thermal Sensor Monitoring of Orthosis Use
4D CT Scan
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis Wrist focused on measuring arthritis, orthotics
Eligibility 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
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
3D Orthosis
Custom Thermoplastic Orthosis
Arm Description
See summary
See summary
Outcomes
Primary Outcome Measures
Change in Disabilities of the Arm Shoulder and Hand Questionnaire.
Patient reported outcome measure
Change in Pain
VAS scale for pain
4D CT Scan Changes
Effectiveness of Orthosis to stabilize CMC while pinching
Secondary Outcome Measures
Adherence
Measured via log book and temperature sensors
Orthosis Satisfaction Survey
Assessment of participants satisfaction with orthosis
Change in Pinch strength
Pinch gauge measurements
Full Information
NCT ID
NCT04297943
First Posted
February 24, 2020
Last Updated
March 3, 2020
Sponsor
Western University, Canada
Collaborators
St. Joseph's Healthcare Foundation, Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT04297943
Brief Title
Orthotic Management of CMC Osteoarthritis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada
Collaborators
St. Joseph's Healthcare Foundation, Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
This study will be prospective, randomized, controlled trial. Patients will be identified for potential inclusion by the surgeons at HULC. The standard of clinical care is for diagnosis of CMC is to perform X-rays of the hand and this is done routinely. Based on these images and clinical evaluation, surgeons will establish a diagnosis of CMC, and provide a grading of severity based on the Eaton/Littler Classification on a referral pad. Eligible participants will then be asked to attend the Clinical Research Laboratory within HULC, where one of the co-investigators listed will present the letter of information and obtain informed consent. Patients who agree to participate will be asked to complete 3 functional outcomes questionnaires (i.e. DASH, PRWHE, and VAS pain scale). Bilateral wrist and thumb range of motion, lateral and tripod pinch strength, and grip strength will also be assessed.
Following the initial assessment, patients will be randomized into one of two groups. Patients will be stratified based on their initial referral by the hand surgeon according to CMC OA severity results to ensure that equal numbers of participants fall into each treatment arm based on the Eaton Classification of their CMC OA. After randomization, patients will attend splinting visit #1 (based on scheduling availability) either the Hand Therapy Department at St. Joseph's Health Care London or Hand Therapy Canada, a private clinic in London. Regardless of group allocation or location of therapy visit, patients will not be charged for their therapy visits or for their splint.
Splinting Visit #1
Group one will be fit with a low temperature custom thermoplastic brace at one of the aforementioned clinic locations and then booked for a follow up appointment in the clinical research laboratory at SJHC two weeks later.
Group two will have their hand placed in a scanner that takes multiple photographs of the hand and reconstructs these photos into a single 3 dimensional computer image. From there, one of the co-investigators (MS) will "draw" the splint, and send to a 3D printer. Patients will come back to a clinic location for fitting, and will then follow up 2 weeks after splint fitting at the clinical research laboratory 2 weeks later.
Regardless of group allocation, each splint will have a temperature sensor placed into the splint. This sensor is similar to a watch battery and collects and records several thousand temperature readings on pre-set intervals. Participants will be told that the the sensor records data on position of the hand in space, but in fact, recording the temperature will provide information about adherence with the splinting program.
CT Scan
Patients undergo a 4D CT scan of bilateral thumb CMC joints. This will include scans at rest, while performing lateral pinch of 2kg, 5kg, and maximum pinch (if greater than 5kg). They will then apply their splint, and these images will be repeated while wearing the splint.
Follow Up Visits
Participants will be asked to wear their splint during most functional activities for 8 weeks, with the goal of wearing their splint for at least half of their waking hours. They will be asked to keep a daily logbook of the amount of time spent in the splint and will keep these records until the 2-month visit. All participants will return to therapy once every 2 weeks. The purpose of these follow up visits will be to download the data from the temperature sensors and to ensure there is no skin irritation or evidence of any skin breakdown from splint use.
2-month visit
At 2 months, participants will be asked to repeat the three functional outcomes questionnaires and will have their ROM and strength re-tested as in visit #1. They will also have a surface EMG recording of their muscle contractions while in the splint. At this point, the sensors will be removed from the splints for final analysis. Patients will also turn in their logbooks of splint usage, and complete a splinting satisfaction questionnaire. They will then attend a second visit to the CT scanner for a repeat imaging session exactly as listed above.
Final Visit
Participants will be call back to the clinic for a final evaluation at 12 months. At this point, all measures will be repeated with the exception of the CT scans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Wrist
Keywords
arthritis, orthotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D Orthosis
Arm Type
Active Comparator
Arm Description
See summary
Arm Title
Custom Thermoplastic Orthosis
Arm Type
Active Comparator
Arm Description
See summary
Intervention Type
Device
Intervention Name(s)
Orthosis fabrication
Intervention Description
see summary
Intervention Type
Device
Intervention Name(s)
Thermal Sensor Monitoring of Orthosis Use
Intervention Description
see summary
Intervention Type
Diagnostic Test
Intervention Name(s)
4D CT Scan
Intervention Description
see summary
Primary Outcome Measure Information:
Title
Change in Disabilities of the Arm Shoulder and Hand Questionnaire.
Description
Patient reported outcome measure
Time Frame
Initial Visit, at 2 month visit, and at 1 year
Title
Change in Pain
Description
VAS scale for pain
Time Frame
Initial Visit, at 2 month visit, and at 1 year
Title
4D CT Scan Changes
Description
Effectiveness of Orthosis to stabilize CMC while pinching
Time Frame
At enrolment and again 2 months later
Secondary Outcome Measure Information:
Title
Adherence
Description
Measured via log book and temperature sensors
Time Frame
Measured at 2 month visit, with data downloaded biweekly
Title
Orthosis Satisfaction Survey
Description
Assessment of participants satisfaction with orthosis
Time Frame
At 2 month visit and at 1 year
Title
Change in Pinch strength
Description
Pinch gauge measurements
Time Frame
Measured in CT scans at enrolment and at 2 month visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
-
12. IPD Sharing Statement
Plan to Share IPD
No
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Orthotic Management of CMC Osteoarthritis
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