Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty

NCT05307510 | Completed Results FDA Device

• 1 other identifier: UToledo301275
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thumb Osteoarthritis

Keywords

Carpometacarpal; Thumb; Arthroplasty; Splints; Function

Outcome Measures

Primary Outcomes (2)

• 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 while using hand.

  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.

  11-12 weeks after surgery

Secondary Outcomes (3)

• Change in the Amount of Thumb CMC Active Range of Motion Post-operatively

  11-12 weeks after surgery

• Change in Client's Self-report of Hand Function Post-operatively as Measured by the QuickDash Disabilities of Arm, Shoulder, and Hand (QuickDASH)

  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

  11-12 weeks after surgery

Other Outcomes (2)

• Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services

  11-12 weeks after surgery

• Change in Presence of Edema Post-operatively as Measured by a Circumferential Measurement

  baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery

Study Arms (2)

Intervention A - prefabricated splint

ACTIVE COMPARATOR

A prefabricated splint is provided to the client

Device: Prefabricated splint

Intervention B - custom orthosis

EXPERIMENTAL

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

Device: Custom Orthosis

Interventions

Prefabricated splint DEVICE

Subjects will be provided either a prefabricated splint

Intervention A - prefabricated splint

Custom Orthosis DEVICE

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

Intervention B - custom orthosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• status post CMC arthroplasty
• or older
• able to read and understand English
• capable of independently consenting to health care procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toledo: lead

Study Sites (1)

University of Toledo Medical Center

Toledo, Ohio, 43606, United States

Location

Limitations and Caveats

The collaborating surgeon's standard practice patterns included the provision of a hand-based thumb orthosis at DC II. This unanticipated standard practice pattern significantly limits conclusions that can be drawn from the data regarding between group differences in the outcomes.

Results Point of Contact

• Title: Laura Schmelzer
• Organization: The University of Toledo

laura.schmelzer@utoledo.edu

419-530-5068

Study Officials

• Laura Schmelzer, PhD

  The University of Toledo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: April 1, 2022
• Study Start: April 21, 2022
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)