Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05896410 |
| Other study ID # |
122173 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Western University, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
