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3D-Printed Hand Orthosis Versus Thermoplastic Orthosis

NCT05896410 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-06-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Western University, Canada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-07-15
Completion
2023-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05896410 on ClinicalTrials.gov