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

University Hospital, Basel, Switzerland1 site in 1 country24 target enrollmentAugust 22, 2019

ConditionsSplints

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Splints
Sponsor: University Hospital, Basel, Switzerland
Enrollment: 24
Locations: 1
Primary Endpoint: Change in patient comfort and satisfaction
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 22, 2019

End Date

February 17, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Basel, Switzerland

Responsible Party

Sponsor

Eligibility Criteria

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