3D Printed Made to Measure Splints for Hand Patients

NCT ID: NCT04306796

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2020-02-17

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).

Detailed Description

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Conditions

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Splints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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intervention group

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

Group Type EXPERIMENTAL

3D printed splints

Intervention Type DEVICE

3D printed made to measure splints

control group

Patients receiving thermoplastic splints individually adjusted by occupational therapists

Group Type ACTIVE_COMPARATOR

Thermoplastic splints

Intervention Type DEVICE

thermoplastic splints individually adjusted by occupational therapists

Interventions

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3D printed splints

3D printed made to measure splints

Intervention Type DEVICE

Thermoplastic splints

thermoplastic splints individually adjusted by occupational therapists

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie,

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2019-00351;ch20Kaempfen

Identifier Type: -

Identifier Source: org_study_id

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