Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty
Primary Purpose
Thumb Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prefabricated splint
Custom Orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Thumb Osteoarthritis focused on measuring Carpometacarpal, Thumb, Arthroplasty, Splints, Function
Eligibility Criteria
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.
Sites / Locations
- University of Toledo Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intervention A - prefabricated splint
Intervention B - custom orthosis
Arm Description
A prefabricated splint is provided to the client
a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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)
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05307510
Brief Title
Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty
Official Title
Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis
Keywords
Carpometacarpal, Thumb, Arthroplasty, Splints, Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention A - prefabricated splint
Arm Type
Active Comparator
Arm Description
A prefabricated splint is provided to the client
Arm Title
Intervention B - custom orthosis
Arm Type
Experimental
Arm Description
a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist
Intervention Type
Device
Intervention Name(s)
Prefabricated splint
Intervention Description
Subjects will be provided either a prefabricated splint
Intervention Type
Device
Intervention Name(s)
Custom Orthosis
Intervention Description
Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.
Primary Outcome Measure Information:
Title
Change in Pain post-operatively using the Visual Analog Scale (Pain VAS)
Description
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.
Time Frame
baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery
Title
Change in Wound Dehiscence post-operatively as measured by Sandy Grading System
Description
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.
Time Frame
baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery
Secondary Outcome Measure Information:
Title
Change in the amount of thumb CMC active range of motion post-operatively
Description
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)
Time Frame
5-6 week after surgery, 11-12 weeks after surgery
Title
Change in client's self-report of hand function post-operatively as measured by the QuickDASH
Description
The QuickDash is a questionnaire about symptoms and ability to perform certain activities. Scores range from 0 (no disability) to 100 (severe disability).
Time Frame
5-6 week after surgery, 11-12 weeks after surgery
Title
Change in the degree of dexterity post-operatively as measured by the applied dexterity portion of the Arthritis Hand Function Test
Description
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.
Time Frame
5-6 week after surgery, 11-12 weeks after surgery
Other Pre-specified Outcome Measures:
Title
Patient satisfaction with device and services as measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction with Device and Services
Description
A 21 item self-report questionnaire to measure satisfaction with device and services. Items 1-15 address services, items 16- 21 address device. Items are scored 0-4, with a higher score indicating higher satisfaction. Total score can range between 0-84.
Time Frame
5-6 weeks after surgery, 11-12 weeks after surgery
Title
Change in presence of edema post-operatively as measured by a circumferential measurement
Description
A circumferential measurement at the base (metacarpal phalangeal joint) of the surgical thumb.
Time Frame
baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Schmelzer, PhD
Phone
4195305068
Email
laura.schmelzer@utoledo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Stotz, OTD
Phone
419.530.6691
Email
nicole.stotz@utoledo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Schmelzer, PhD
Organizational Affiliation
The University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Osten
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty
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