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Waldburger, et al.
hand splints, despite the importance of patient-reported design were defined by clinical standards regardless of
outcome measurements designed for this purpose. the study group allocation.
Only the Client Satisfaction with Device part of the Quality was assessed at 3 time points during regular
Orthotics and Prosthetics Users’ Survey includes some occupational therapy sessions: Directly after splint
questions on patient satisfaction with their prosthesis adjustment (Questionnaire 1 in Appendix), 2 weeks
or orthosis [17] . after splint adjustment (Questionnaire 2 in Appendix),
Personalized made-to-measure splints, based on and 4–6 weeks after splint adjustment at the end of
a 3D surface scan, could provide clinically equivalent the patient’s study participation (Questionnaire 3 in
fit and comfort. We hypothesized that higher patient Appendix). Figure 1 shows a summary of the study
satisfaction would lead to better wearing compliance, timeline.
fewer complications such as pressure sores, and faster
rehabilitation. To test our hypothesis, we aimed, as a first 2.1. Ethics statement
step in this pilot study, to evaluate the general feasibility This study was approved by the Ethikkommission
and possible benefits of splint production by 3D printing Nordwest- und Zentralschweiz (EKNZ- 2019-00351).
in a clinical setting. To the best of our knowledge, this is Written informed consent was obtained from the patients
the first randomized clinical trial to test 3D-printed splints for their anonymized information to be published in this
in a wide range of hand pathologies and to compare them article.
to widely used standard thermoplastic splints.
2.2. Device production
2. Methods
All patients of the control group were treated with
We conducted a randomized controlled pilot trial at the a custom-made splint from thermoplastic material,
hand surgical clinic of our university hospital. Here, we fabricated by an experienced occupational therapist
used plaster casts and ready-made braces for provisional (Figure 2). For patients of the 3D group, splint
acute immobilization. Later, occupational therapists production occurred between study inclusion and the
fabricate custom-made thermoplastic splints for the first occupational therapy appointment. Therefore, a 3D
injured hand as a more beneficial and pathology-tailored surface scan of the patient’s affected hand was obtained
solution. In our experience, however, these splints often at an additional meeting. The splint was then designed
need readjustment due to unsatisfactory fit, especially by the first author after basic training in 3-matic®, in
subsequent to heavy initial swelling. accordance with the recommendations of an experienced
Patients were eligible to participate in our study occupational therapist. The 3D splint design was kept
if they had an indication for immobilization for at
least 4 weeks after trauma, underwent post-operative
rehabilitation, or experienced chronic pain. Eligible
participants had to be at least 18 years old and able to
provide written informed consent. We made no exclusions
because of certain pathological condition or splint design
to achieve the widest possible range of patients and to
“imitate” future use of 3D splints. Patients were, therefore,
excluded only if they had tissue loss, an external fixation,
documented hypersensitivity reactions to polylactic acid
(PLA), drug or alcohol abuse, or inability to follow the
procedures of the study because of other medical or
cognitive conditions. In the case of a second indication
for immobilization during the study period, patients were
not enrolled a 2 time. All participants were randomized
nd
through envelope draw to two equally sized groups: An
interventional 3D group and a control group with standard
thermoplastic splints. Blinding was not feasible.
All patients initially received a provisional
immobilization device. Between days 2 and 5 after study
inclusion, patients presented to occupational therapy
for the handover and adjustment (3D group) or direct
production (control group) of their individualized splint.
Treatment algorithms of pathological condition and splint Figure 1. Summary of the study timeline.

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