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3D Printed Made to Measure Splints for Hand Patients

University Hospital Basel logo

University Hospital Basel

Status

Completed

Conditions

Splints

Treatments

Device: Thermoplastic splints
Device: 3D printed splints

Study type

Interventional

Funder types

Other

Identifiers

NCT04306796
2019-00351 ch20Kaempfen;

Details and patient eligibility

About

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).

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

intervention group
Experimental group
Description:
Patients receiving 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients
Treatment:
Device: 3D printed splints
control group
Active Comparator group
Description:
Patients receiving thermoplastic splints individually adjusted by occupational therapists
Treatment:
Device: Thermoplastic splints

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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