3D Printed Made to Measure Splints for Hand Patients

3D Printed Made to Measure Splints for Hand Patients - Pilot Feasibility Study and Socioeconomic Evaluation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04306796

Enrollment

Registered

2020-03-13

Start date

2019-08-22

Completion date

2020-02-17

Last updated

2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Splints

Keywords

hand trauma, splint, made to measure, 3D print

Brief summary

This study aims to evaluate the feasibility and possible benefits of 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients (intervention group) in comparison to thermoplastic splints individually adjusted by occupational therapists (control group).

Interventions

DEVICE3D printed splints

3D printed made to measure splints

DEVICEThermoplastic splints

thermoplastic splints individually adjusted by occupational therapists

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients presenting to the hand surgical department of the University Hospital Basel * Patients with hand trauma w/wo the need for hand surgery or patient with planned elective hand surgical intervention * Indication for immobilization of at least 4 weeks * Older than 18 years * Capable of consent * Informed Consent as documented by signature

Exclusion criteria

* Open wounds with tissue loss * Injury with the need for external fixation * Younger than 18 years * Not capable of consent * Asymmetric deformity or loss of the contra-lateral hand * Documented hypersensitivity or allergy to Polylactic acid * Known or suspected non-compliance to agreed treatment measures and/or unexcused nonappearance to hospital appointments * Drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Previous enrolment into the current study

Design outcomes

Primary

Measure	Time frame	Description
Change in patient comfort and satisfaction	at 2-5 days after trauma and/or surgery	questionnaire 1. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026