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Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty

Not Applicable
Completed
Conditions
Thumb Osteoarthritis
Interventions
Device: Custom Orthosis
Device: 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention B - custom orthosisCustom Orthosisa custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist
Intervention A - prefabricated splintPrefabricated splintA prefabricated splint is provided to the client
Primary Outcome Measures
NameTimeMethod
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 System11-12 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
NameTimeMethod
Change in the Amount of Thumb CMC Active Range of Motion Post-operatively11-12 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 Test11-12 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

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