3D-Printed Hand Orthosis Versus Thermoplastic Orthosis

Comparison of Using 3D-Printed Hand Orthosis Versus Thermoplastic Orthosis in Patients With Thumb Carpo-metacarpal Osteoarthritis: A Pilot Randomized Trial Cross-over Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Splints; Thumb Osteoarthritis; CMC
• Intervention / Treatment: Device: splint (orthosis)

Detailed Description

Non-surgical treatment is the initial consideration for symptomatic carpometacarpal (CMC) osteoarthritis (OA). Immobilization with orthosis (splint) is one of the methods of non-surgical treatment. The evidence is mounting regarding the effectiveness of orthosis in OA of the thumb. A recent systematic review indicated that splinting causes a moderate to large effect on pain. However, a recent network meta-analysis showed that a short thermoplastic CMC splint is the best treatment to increase function.

The variations of the recommended orthosis for immobilization of the CMC are varied from the neoprene splints to the rigid thermoplastic material. However, the patient's satisfaction with these materials is different. Patients reported more satisfaction with neoprene thumb splints but found custom-made splints more functional.

Hand therapists typically use low-temperature thermoplastic materials (LTTP) for orthosis fabrication.

3D-printed orthoses are emerging as an alternative for immobilizing joints. Different studies tried to compare the two methods of the 3D printed orthosis with a thermoplastic orthosis and reported some advantages for a 3D printed orthosis. These studies reported advantages including being lighter in weight, producing less incidence of skin irritation, offering better hygiene with less odour and perspiration, appealing and custom-tailored aesthetic design, and the ability to use recycled affordable materials. Furthermore, the fabrication of thermoplastic orthosis needs expertise and knowledge, which require specialized training to fabricate and are time-consuming, expensive, difficult to keep clean, bulky, cumbersome, and unable to tolerate moisture at high temperatures. Also, the thermoplastic material is subject to cracking, requiring the patient to go through the healthcare system again and return to the clinic just for a therapist to make another splint. Off-the-shelf splints have better breathability and longevity but cost more and are often less form-fitting or stabilizing than a therapist-made splint. Despite the numerous advantages of the 3D printed splint listed in the literature, the high cost of equipment, lack of training and skill of clinicians and the long time required for production limited their use in hand therapy.

Progress has been made in developing the 3D of orthoses. Potential advantages include comfort, well-fitting, adequate ventilation in the splint and a clean production process. However, there are challenges in reducing the reliance on the in-person evaluation given the complex geometries of the hand, unavailability of high-resolution scanners, fabrication time that may require multiple visits and cost, equipment materials and expertise. Accurate and high-resolution 3D scanners are available on the market and are currently used in research studies. Different scanners are being used in the literature to scan the hand. Different steps are required to fabricate a 3D printed orthosis, including scanning the body segment with a 3D scanner, CT scan or MRI; transferring the scanned data to a computer modelling software program; printing the orthosis; and finishing/adjusting the final product. The time needed to scan the affected upper limb ranged from 1 to 3 minutes. The time needed to modify the scanned digital file in a computer-aided design software program to be ready for 3D printing was reported to take approximately 1 hour. Only one study reported a 53% reduction in total fabrication time with a 3D-printed orthosis compared with a traditional orthosis.

Few studies compared 3D-printed orthosis with traditional orthosis fabrication in the clinical setting. The reported outcome measures are Outcome measures pain, overall satisfaction, and function. More satisfaction, less skin irritation, itchiness and odour; however, none utilize patients with CMC OA as participants. Chu et al. used 3D hand parametric modelling techniques to create customized designs of short thumb orthoses in healthy adults. They reported that the 3D-printed orthosis provided greater flexibility of hand movement and stronger support than the traditional, manually formed orthosis.

There is a gap in evidence regarding the clinical utility and feasibility of using 3D printing versus traditional orthosis in patients with CMC joint OA.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thermoplastic Splint(orthosis); 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) 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.; Other Names: 3D printed splint (orthosis)
Experimental: 3D printed splint (orthosis); 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); 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.; Other Names: 3D printed splint (orthosis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in hand Function	The shortened form of the Disability of the Arm, Shoulder, and Hand Questionnaire (Quick DASH) will be used to measure the upper extremity function . This tool consists of 11 items and a total score ranging from 0 to 100, where 0 indicates no limitation and 100 suggests full disability. Eight questions inquire about the patient's ability to perform certain daily activities.	baseline and after each orthosis use((three weeks and six weeks))
weight of splint (orthosis)	will be evaluated by Gram	after each orthosis preperation(baseline)
preparation time for each splint	length of the time will be recorded for each splint (orthosis).	after each orthosis preperation (baseline)
Change of Pain at CMC joint	Pain will be evaluated by the Numeric Rating Scale (NRS).The NRS is a reliable instrument with demonstrated sensitivity to changes in pain in patients with chronic inflammatory or degenerative pain.	baseline and after each orthosis use(three weeks and six weeks)

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): July 15, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: 3D print; Splint; Thumb osteoarthrities; CMC; low temprature thermoplastic
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 122173

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: No