Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures
NCT ID: NCT05346926
Last Updated: 2022-04-26
Study Results
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-03-01
2021-12-31
Brief Summary
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Detailed Description
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Upon the patient's arrival at the emergency unit, the distal radius fracture is examined following the same scheme as before. The wrist is x-rayed in two planes. If there is a distal radius fracture and none of the exclusion criteria apply, the patient is included in the study after giving their consent in writing. The patients are then assigned to the "conventional cast" group (Group A) or the "3D print cast" group (Group B) in randomized trial, either immediately during the emergency consultation or within a week during hand surgery consultation hours. For initial immobilization, a thermoplastic cast splint is used as before. Depending on the randomization, the cast is changed to a Scotchcast cast (Group A) or a 3D printed cast (Group B). Further treatment of both groups occurs based on the same algorithm as before (see below).
The cast for Group B are produced using 3D print technology based on software by a Belgian company, our collaborators: The patient's forearm is scanned with a tablet (duration: approx. 5 min), whereupon the cast is printed overnight according to the scan (duration: approx. 4h) and adjusted to the patient during the next appointment.
The patients are examined after 1, 6, 12, 26 and 52 weeks in the outpatient clinic. Follow up x rays, patient satisfaction and clinical efficacy questionnaires and clinical examinations are conducted.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3D-printed cast
Treatment of distal radius fracture with 3D-printed forearm cast.
3D-printed cast
The 3D-printed casts are produced using 3D print technology based on software by Belgian software company: The patient's forearm is scanned with a tablet (duration: approx. 5 min), whereupon the cast is printed overnight according to the scan (duration: approx. 4h) and adjusted to the patient during the next appointment.
Conventional cast
Treatment of distal radius fracture with conventional plaster cast.
Conventional cast
A conventional plaster cast is applied for treatment of the distal radius fracture.
Interventions
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3D-printed cast
The 3D-printed casts are produced using 3D print technology based on software by Belgian software company: The patient's forearm is scanned with a tablet (duration: approx. 5 min), whereupon the cast is printed overnight according to the scan (duration: approx. 4h) and adjusted to the patient during the next appointment.
Conventional cast
A conventional plaster cast is applied for treatment of the distal radius fracture.
Eligibility Criteria
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Inclusion Criteria
* Undisplaced or minimally displace distal radius fractures
Exclusion Criteria
2. Dorsal dislocation (dp angle) \>20°
3. Palmar dislocation
4. Ad latus dislocation
5. Radio-/ulnar angulation in the coronary plane
6. Symptoms of neurologic affection (Median nerve)
7. Bilateral fractures
8. Previous ipsilateral distal radius fracture
9. The patient is unable to give informed consent due to physical or mental impairment
10. The patient is unavailable for follow-up examinations (foreign country, Polytrauma, etc)
11. The patient is under legal custodianship
12. C2- or Drug-abuse or expected incompliance
13. Hypersensitivity/Allergy to one or more components of the used casts
14. Pregnancy/Intention to become pregnant during the course of the study
18 Years
ALL
No
Sponsors
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Spentys
INDUSTRY
Alissa Gubeli
OTHER
Responsible Party
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Alissa Gubeli
Junior Consultant Hand Surgery
Principal Investigators
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Philipp Honigmann, PD Dr. med.
Role: STUDY_DIRECTOR
Cantonal Hosptal, Baselland
Locations
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Kantonsspital Baselland
Bruderholz, Basel-Landschaft, Switzerland
Countries
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Other Identifiers
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2019-01644
Identifier Type: -
Identifier Source: org_study_id
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