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CompletedNCT04306796Updated Jun 16, 2020

3D Printed Made to Measure Splints for Hand Patients

An interventional study of 3D printed splints and Thermoplastic splints in Splints, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2019, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Splints

Keywords

  • hand trauma
  • splint
  • made to measure
  • 3D print
03

In context

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    intervention group

    Patients receiving 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients

    Device: 3D printed splints

  • Active comparator
    control group

    Patients receiving thermoplastic splints individually adjusted by occupational therapists

    Device: Thermoplastic splints

Interventions

  • Device3D printed splints

    3D printed made to measure splints

  • DeviceThermoplastic splints

    thermoplastic splints individually adjusted by occupational therapists

06

What researchers measure

Primary outcomes

  1. Change in patient comfort and satisfaction

    questionnaire 1. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)

    Time frame: at 2-5 days after trauma and/or surgery

  2. Change in patient comfort and satisfaction

    questionnaire 2. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)

    Time frame: at 2 weeks of immobilization during a routine control visit

  3. Change in patient comfort and satisfaction

    questionnaire 3. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)

    Time frame: at 6 weeks of immobilization during what is usually the concluding visit of treatment

07

Study locations

1 site
  • Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie,
    Basel, 4035, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04306796
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Mar 13, 2020
Start date
Aug 22, 2019
Primary completion
Feb 17, 2020
Completion
Feb 17, 2020
Last update
Jun 16, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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