Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2023-10-27

Brief Summary

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This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty.

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Detailed Description

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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

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Thumb Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention A - prefabricated splint

A prefabricated splint is provided to the client

Group Type ACTIVE_COMPARATOR

Prefabricated splint

Intervention Type DEVICE

Subjects will be provided either a prefabricated splint

Intervention B - custom orthosis

a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist

Group Type EXPERIMENTAL

Custom Orthosis

Intervention Type DEVICE

Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.

Interventions

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Prefabricated splint

Subjects will be provided either a prefabricated splint

Intervention Type DEVICE

Custom Orthosis

Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes