3D Printed Made to Measure Splints for Hand Patients

Study Overview
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Brief Summary
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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).

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

Conditions
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Splints

Intervention / Treatment
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* Device: 3D printed splints
* Device: Thermoplastic splints


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Patients receiving 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients | Device: 3D printed splints<br>* 3D printed made to measure splints<br>|
| Active Comparator: control group<br>Patients receiving thermoplastic splints individually adjusted by occupational therapists | Device: Thermoplastic splints<br>* thermoplastic splints individually adjusted by occupational therapists<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | at 2-5 days after trauma and/or surgery | 
| 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) | at 2 weeks of immobilization during a routine control visit | 
| 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) | at 6 weeks of immobilization during what is usually the concluding visit of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand trauma, splint, made to measure, 3D print