Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty

Study Overview
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Brief Summary
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This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty.

Detailed Description
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This research study will randomly assign subjects post CMC arthroplasty to Intervention A (prefabricated splint) or Intervention B (custom orthosis). The orthosis and splint being used in this study are both considered standard practice. Subjects will be provided the splint or orthosis at the first post-operative appointment. Subjects who are assigned to Intervention A will be provided a pre-fabricated splint by a member of the surgical team. Subjects who are assigned to Invention B will be evaluated by an occupational therapist and a custom orthosis will be fabricated. Outcome measures include: QuickDASH, Pain Visual Analogue Scale, active range of motion measurements, the Applied Dexterity portion of the Arthritis Hand Function Test except for the putty cutting task, edema, Sandy Grading Score and the Orthotics and Prosthetics User's Survey (OPUS) Satisfaction with Device and Services. Data will be collected at the first, second, and third post-operative appointment.

Official Title
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Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty

Conditions
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Thumb Osteoarthritis

Intervention / Treatment
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* Device: Prefabricated splint
* Device: Custom Orthosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: status post CMC arthroplasty 18 or older able to read and understand English capable of independently consenting to health care procedures. Exclusion Criteria: if the surgeon identifies risk factors that would preclude random assignment to the control or experimental group if subject requests a prefabricated or custom orthosis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention A - prefabricated splint<br>A prefabricated splint is provided to the client | Device: Prefabricated splint<br>* Subjects will be provided either a prefabricated splint<br>|
| Experimental: Intervention B - custom orthosis<br>a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist | Device: Custom Orthosis<br>* Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain post-operatively using the Visual Analog Scale (Pain VAS) | The Pain Visual Analog Scale is a self-report measure of pain with a range of 0= no pain - 10 = worst pain. Subjects report pain at rest, at night, and while using hand. | baseline ( 10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery | 
| Change in Wound Dehiscence post-operatively as measured by Sandy Grading System | Sandy Grading System is a scale used to measure wound dehiscence. Scale contains 6 grades (I, Ia, II, Ia, III, IIIa). A grade of I indicates no clinical signs of microbiological confirmation of infection and IIIa indicates presence of clinical signs and confirmed microbiological confirmation of infection. The higher number indicates increased presence of infection. | baseline ( 10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the amount of thumb CMC active range of motion post-operatively | Goniometric measurements for active radial and palmar abduction will determine the amount of active movement. More range indicates better movement (0-50 = radial abduction norms) (0-70 = palmar abduction norms) | 5-6 week after surgery, 11-12 weeks after surgery | 
| Change in client's self-report of hand function post-operatively as measured by the QuickDASH | The QuickDash is a questionnaire about symptoms and ability to perform certain activities. Scores range from 0 (no disability) to 100 (severe disability). | 5-6 week after surgery, 11-12 weeks after surgery | 
| Change in the degree of dexterity post-operatively as measured by the applied dexterity portion of the Arthritis Hand Function Test | Four of Five items (fasten and unfasten buttons, lace a shoe and tie a bow, pin and unpin two safety pins in a cloth, pick up and manipulate four coins into a slot) will be completed. Each task will be timed. A shorter amount of time indicates better dexterity. | 5-6 week after surgery, 11-12 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carpometacarpal, Thumb, Arthroplasty, Splints, Function