3D-Printed Hand Orthosis Versus Thermoplastic Orthosis

NCT05896410 | Unknown DMC

• 1 other identifier: 122173
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate the effectiveness of 3D-printed splints for treating thumb osteoarthritis (CMC OA). These splints are made by Occupational Therapists and Physical Therapists out of low-temperature plastic and formed on the patient's hand. 3D printed splints involve photographing the hand and creating a digital file of the splint. This is then printed and fit on the patient. The goal of this cross-over clinical trial is to compare the effectiveness of 3D-printed splints versus thermoplastic splints for treating thumb osteoarthritis (CMC OA). The main question\[s\] it aims to answer are: Primary objective:

• Evaluate the general useability and possible benefits of splint production by 3D printing in a clinical setting Secondary objectives:
• Compare the effectiveness of 3D printed orthosis and the low-temperature plastic fabrication manual method in pain reduction
• Compare the effectiveness of 3D printed orthosis and the low-temperature plastic fabrication manual method in improving the function.
• Compare the satisfaction of patients with the 3D printed orthosis and low-temperature plastic fabrication manual method.
• Compare the length of time needed to fabricate each orthosis
• Compare the weight of orthosis Participants will provide with two splints (traditional orthosis and 3D-printed orthoses). Participants will use the first orthosis for three weeks, be given a week for washout, and then cross over to the second orthosis.

Conditions

Thumb Osteoarthritis; CMC; Splints

Keywords

Thumb osteoarthrities; CMC; Splint; 3D print; low temprature thermoplastic

Outcome Measures

Primary Outcomes (1)

• Feasibility and general useability

  The feasibility of splint production by 3D printing in a clinical setting will be evaluated by evaluating the degree to which a new intervention is considered suitable, satisfying, or with The Quebec User Evaluation of Satisfaction with Assistive Technology 2(QUEST-2) questionnaire. It is a 12-item outcome measure that assesses user satisfaction with two components, Devices and Services. Psychometric properties have been tested with respect to test-retest stability, alternate-form equivalence, internal consistency, factorial composition and nomological validity. Each item of the QUEST is scored on a 5-point satisfaction scale of zero to 5, which the score for fully agreeing being "5". The score ranges from 0-60, with a higher score indicating more satisfaction with Assistive Technology.

  At six weeks

Secondary Outcomes (4)

• Changes in hand Function

  baseline and after each orthosis use((three weeks and six weeks))

• weight of splint (orthosis)

  after each orthosis preperation(baseline)

• preparation time for each splint

  after each orthosis preperation (baseline)

• Change of Pain at CMC joint

  baseline and after each orthosis use(three weeks and six weeks)

Study Arms (2)

Thermoplastic Splint(orthosis)

ACTIVE COMPARATOR

A static hand-based splint (orthosis) made with a thermoplastic material that immobilizes the CMC and MCP joint will be used.

Device: splint (orthosis)

3D printed splint (orthosis)

EXPERIMENTAL

A static hand-based 3D-printed splint (orthosis) made with 3D printing that immobilizes both the CMC and MCP joint will be used.

Device: splint (orthosis)

Interventions

splint (orthosis) DEVICE

3D printed splint (orthosis) help prevent the joint from shifting during pinch activities. This reduces improper joint loading and helps reduce pain and the progression of degenerative change in patients with OA.

Also known as: 3D printed splint (orthosis)

3D printed splint (orthosis); Thermoplastic Splint(orthosis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Patients would be eligible to participate in our study : * At least 18 years old, * able to provide written informed consent * indicating immobilization of CMC as part of their therapy. The orthosis treatment can be in any part of their treatment (first users or the patients with experience of using orthosis). Patients will be excluded if * have skin irritation, blister, or wound. * have neurologic conditions affecting their pain perception in the upper limb.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Western University, Canada: lead

MeSH Terms

Interventions

Splints; Orthotic Devices

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study, participants act as their controls; traditional orthosis and 3D-printed orthoses. The order of intervention and testing conditions will be determined by drawing a concealed envelope from a bag . The testing protocol will be started after the fitting of orthoses. Participants will use the first orthosis for three weeks, be given a week for washout, and then cross over to the second orthosis. The participants should use the second orthosis for three weeks. All participants will be informed about the research details, and the measurements will be explained and demonstrated to the participant and provided signed informed consent before participation. Patients will receive identical orthotic-wearing instructions. Patients will be asked to use the orthosis during the daytime functional activities and ADLs for at least half of their waking hours. All patients will be asked to report any pain, discomfort, or skin irritations when using the orthosis.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: June 9, 2023
• Study Start: June 1, 2023
• Primary Completion: July 15, 2023
• Study Completion: August 1, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share