University of Toledo
This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty.
Thumb Osteoarthritis
Prefabricated splint
Custom Orthosis
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 125 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty |
| Actual Study Start Date : | 2022-04-21 |
| Estimated Primary Completion Date : | 2024-01 |
| Estimated Study Completion Date : | 2024-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Toledo Medical Center
Toledo, Ohio, United States, 43606