3D Printed Made to Measure Splints for Hand Patients

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

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).

Study Overview

• Status: Completed
• Conditions: Splints
• Intervention / Treatment: Device: 3D printed splints; Device: Thermoplastic splints

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4035
    • Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: splint; 3D print; hand trauma; made to measure
• Other Study ID Numbers: 2019-00351;ch20Kaempfen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No