Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty
- Conditions
- Thumb Osteoarthritis
- Interventions
- Device: Custom OrthosisDevice: Prefabricated splint
- Registration Number
- NCT05307510
- Lead Sponsor
- University of Toledo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- status post CMC arthroplasty
- 18 or older
- able to read and understand English
- capable of independently consenting to health care procedures.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention B - custom orthosis Custom Orthosis a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist Intervention A - prefabricated splint Prefabricated splint A prefabricated splint is provided to the client
- Primary Outcome Measures
Name Time Method Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) 11-12 weeks after surgery 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 while using hand.
Change in Wound Dehiscence Post-operatively as Measured by Sandy Grading System 11-12 weeks after surgery 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
Name Time Method Change in the Amount of Thumb CMC Active Range of Motion Post-operatively 11-12 weeks after surgery 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 Disabilities of Arm, Shoulder, and Hand (QuickDASH) 11-12 weeks after surgery 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 11-12 weeks after surgery 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.
Trial Locations
- Locations (1)
University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States