Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty

Thumb Osteoarthritis Clinical Trial

Official title:

Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307510
• Other study ID #: UToledo301275
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: January 2024

Study information

• Verified date: April 2022
• Source: University of Toledo
• Contact: Laura Schmelzer, PhD
• Phone: 4195305068
• Email: laura.schmelzer[@]utoledo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Device:
• Prefabricated splint
Subjects will be provided either a prefabricated splint
• Custom Orthosis
Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.

Locations

Country	Name	City	State
United States	University of Toledo Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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