Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty

Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty

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

Study Overview

• Status: Recruiting
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Device: Prefabricated splint; Device: Custom Orthosis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Schmelzer, PhD; Phone Number: 4195305068; Email: laura.schmelzer@utoledo.edu
• Study Contact Backup: Name: Nicole Stotz, OTD; Phone Number: 419.530.6691; Email: nicole.stotz@utoledo.edu

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • University of Toledo Medical Center
      • Contact: Dan Osten

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention A - prefabricated splint; A prefabricated splint is provided to the client	Device: Prefabricated splint; Subjects will be provided either a prefabricated splint
EXPERIMENTAL: Intervention B - custom orthosis; a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist	Device: Custom Orthosis; Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain post-operatively using the Visual Analog Scale (Pain VAS)	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 at rest, at night, and while using hand.	baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery
Change in Wound Dehiscence post-operatively as measured by Sandy Grading System	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.	baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the amount of thumb CMC active range of motion post-operatively	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)	5-6 week after surgery, 11-12 weeks after surgery
Change in client's self-report of hand function post-operatively as measured by the QuickDASH	The QuickDash is a questionnaire about symptoms and ability to perform certain activities. Scores range from 0 (no disability) to 100 (severe disability).	5-6 week after surgery, 11-12 weeks after surgery
Change in the degree of dexterity post-operatively as measured by the applied dexterity portion of the Arthritis Hand Function Test	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.	5-6 week after surgery, 11-12 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with device and services as measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction with Device and Services	A 21 item self-report questionnaire to measure satisfaction with device and services. Items 1-15 address services, items 16- 21 address device. Items are scored 0-4, with a higher score indicating higher satisfaction. Total score can range between 0-84.	5-6 weeks after surgery, 11-12 weeks after surgery
Change in presence of edema post-operatively as measured by a circumferential measurement	A circumferential measurement at the base (metacarpal phalangeal joint) of the surgical thumb.	baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Toledo
• Investigators: Principal Investigator: Laura Schmelzer, PhD, The University of Toledo

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 21, 2022
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (ACTUAL): April 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Arthroplasty; Function; Thumb; Splints; Carpometacarpal
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: UToledo301275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes