Status:
COMPLETED
Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures
Lead Sponsor:
Alissa Gubeli
Collaborating Sponsors:
Spentys
Conditions:
Radius Fracture Distal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this prospective randomized trial is the acquisition and evaluation of data to assess the relevance, feasibility and safety of forearm casts based on 3D-printing technology in the nonoperat...
Detailed Description
The study design is planned according to similar studies investigating the treatment of distal radius fractures. Upon the patient's arrival at the emergency unit, the distal radius fracture is examin...
Eligibility Criteria
Inclusion
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Undisplaced or minimally displace distal radius fractures
Exclusion
- Age \< 18yrs.
- Dorsal dislocation (dp angle) \>20°
- Palmar dislocation
- Ad latus dislocation
- Radio-/ulnar angulation in the coronary plane
- Symptoms of neurologic affection (Median nerve)
- Bilateral fractures
- Previous ipsilateral distal radius fracture
- The patient is unable to give informed consent due to physical or mental impairment
- The patient is unavailable for follow-up examinations (foreign country, Polytrauma, etc)
- The patient is under legal custodianship
- C2- or Drug-abuse or expected incompliance
- Hypersensitivity/Allergy to one or more components of the used casts
- Pregnancy/Intention to become pregnant during the course of the study
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05346926
Start Date
March 1 2020
End Date
December 31 2021
Last Update
April 26 2022
Active Locations (1)
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1
Kantonsspital Baselland
Bruderholz, Basel-Landschaft, Switzerland, 4101