3D Printed Made to Measure Splints for Hand Patients

Not Applicable

Completed

• Conditions: Splints
• Interventions: Device: 3D printed splints; Device: Thermoplastic splints

• Registration Number: NCT04306796
• Lead Sponsor: University Hospital, Basel, Switzerland

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-22
• Primary Completion: 2020-02-17
• Study Completion: 2020-02-17
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-13
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	3D printed splints	Patients receiving 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients
control group	Thermoplastic splints	Patients receiving thermoplastic splints individually adjusted by occupational therapists

Primary Outcome Measures

Name	Time	Method
Change in patient comfort and satisfaction	at 6 weeks of immobilization during what is usually the concluding visit of treatment	questionnaire 3. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)

Trial Locations

Locations (1)

Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie,; 🇨🇭 Basel, Switzerland