NCT05307510

Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty

Completed NA Results posted Last updated 8 October 2024

What this trial tests

NA trial testing Prefabricated splint in Thumb Osteoarthritis in 21 participants. Completed in 27 October 2023.

Timeline

21 April 2022

Primary endpoint
27 October 2023

27 October 2023

Quick facts

Lead sponsor	University of Toledo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	21 April 2022
Primary completion	27 October 2023
Estimated completion	27 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Prefabricated splint
• Custom Orthosis

Conditions studied

• Thumb Osteoarthritis — all drugs for Thumb Osteoarthritis →

Sponsor

University of Toledo

Who can join

18 and older, any sex, with Thumb Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) Primary · 11-12 weeks after surgery

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.

Pain at rest

Group	Value	95% CI
Intervention A - Prefabricated Splint	2.5	± 2.1
Intervention B - Custom Orthosis	4.2	± 1.3

Pain at night

Group	Value	95% CI
Intervention A - Prefabricated Splint	5.3	± .816
Intervention B - Custom Orthosis	5.8	± 2.6

Pain in use

Group	Value	95% CI
Intervention A - Prefabricated Splint	5	± 2.76
Intervention B - Custom Orthosis	6	± 1.9

Change in Wound Dehiscence Post-operatively as Measured by Sandy Grading System Primary · 11-12 weeks after surgery

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.

Group	Value	95% CI
Intervention A - Prefabricated Splint	1	± 0
Intervention B - Custom Orthosis	1	± 0

Change in the Amount of Thumb CMC Active Range of Motion Post-operatively Secondary · 11-12 weeks after surgery

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)

Palmar Abduction

Group	Value	95% CI
Intervention A - Prefabricated Splint	37.50	± 11.5
Intervention B - Custom Orthosis	41	± 12

Radial Abduction

Group	Value	95% CI
Intervention A - Prefabricated Splint	39.5	± 7.1
Intervention B - Custom Orthosis	42.6	± 8.3

Change in Client's Self-report of Hand Function Post-operatively as Measured by the QuickDash Disabilities of Arm, Shoulder, and Hand (QuickDASH) Secondary · 11-12 weeks after surgery

The QuickDash is a questionnaire about symptoms and ability to perform certain activities. Scores range from 0 (no disability) to 100 (severe disability).

Group	Value	95% CI
Intervention A - Prefabricated Splint	48	± 15.6
Intervention B - Custom Orthosis	40.6	± 8.5

Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test Secondary · 11-12 weeks after surgery

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.

Buttoning Buttons

Group	Value	95% CI
Intervention A - Prefabricated Splint	.36	± .12
Intervention B - Custom Orthosis	.36	± .11

Lacing and tying a shoe

Group	Value	95% CI
Intervention A - Prefabricated Splint	1.37	± .22
Intervention B - Custom Orthosis	1.35	± .35

Opening and closing safety pins

Group	Value	95% CI
Intervention A - Prefabricated Splint	.31	± .13
Intervention B - Custom Orthosis	.33	± .05

Managing coins

Group	Value	95% CI
Intervention A - Prefabricated Splint	.18	± .05
Intervention B - Custom Orthosis	.14	± .02

Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services Secondary · 11-12 weeks after surgery

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.

Satisfaction with orthosis

Group	Value	95% CI
Intervention A - Prefabricated Splint	42.6	± 9.85
Intervention B - Custom Orthosis	45	± 6.57

Satisfaction with services

Group	Value	95% CI
Intervention A - Prefabricated Splint	42	± 4.76
Intervention B - Custom Orthosis	45	± 5.76

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.