3D Printed Made to Measure Splints for Hand Patients

Not Applicable

Completed

• Conditions: 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

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