NCT05307510

Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty

Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Toledo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Thumb Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Prefabricated splint	Subjects will be provided either a prefabricated splint
DEVICE	Custom Orthosis	Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.

Timeline

• Start date: 2022-04-21
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2022-04-01
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study