3D Printed Made to Measure Splints for Hand Patients

Splints Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306796
• Other study ID #: 2019-00351;ch20Kaempfen
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: February 17, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 17, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Splints

Intervention

Device:
• 3D printed splints
3D printed made to measure splints
• Thermoplastic splints
thermoplastic splints individually adjusted by occupational therapists

Locations

Country	Name	City	State
Switzerland	Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie,	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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