3D Printed Made to Measure Splints for Hand Patients

NCT04306796 | Completed

• 1 other identifier: 2019-00351;ch20Kaempfen
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Splints

Keywords

hand trauma; splint; made to measure; 3D print

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

intervention group

EXPERIMENTAL

Patients receiving 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients

Device: 3D printed splints

control group

ACTIVE COMPARATOR

Patients receiving thermoplastic splints individually adjusted by occupational therapists

Device: Thermoplastic splints

Interventions

3D printed splints DEVICE

3D printed made to measure splints

intervention group

Thermoplastic splints DEVICE

thermoplastic splints individually adjusted by occupational therapists

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie,

Basel, 4035, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 13, 2020
• Study Start: August 22, 2019
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

CH (1)