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Effects of Preoperative 3D Printing of Distal Intra-articular Radius Fractures on Quality of Fracture Reduction

Effects of Preoperative 3D Printing of Distal Intra-articular Radius Fractures on Quality of Fracture Reduction: a Randomized, Single-blinded, Monocentric Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05739240
Acronym
3PAS
Enrollment
80
Registered
2023-02-22
Start date
2023-03-01
Completion date
2025-03-31
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

3D Printing, Distal Radius Fracture

Brief summary

The investigators aim to evaluate the effect of a preoperative 3D printed Model (3PAS) of distal intraarticular radius fractures on quality of fracture reduction. Surgical procedure is equal in the 3PAS and in the conventional group. To evaluate the quality of fracture reduction each patient receives a postoperative CAT-scan.

Interventions

PROCEDUREOsteosynthesis

Osteosynthesis of distal radius fractures

Sponsors

Vilijam Zdravkovic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patient older than 18 years * Surgery criteria fulfilled * Informed consent * Intra-articular Fracture of the distal radius (AO 23-B and 23-C) (also including Avulsion of the processus styloideus ulnae AO/OTA 2U3A1.1) in preoperative CAT-Scan

Exclusion criteria

* Patient does not want a surgical treatment * Patient does not want to participate * Positive history for surgery due to injury of the hurt wrist beforehand * Positive history for surgery due to injury of the opposite wrist beforehand * Additional injuries to the hand and forearm (except distal ulna fracture AO 2U3A1.1) * Pregnancy * Vulnerable people * Distal ulna fracture (except AO 2U3A1.1) * Extraarticular radius fracture (AO 23-A) * Concomitant injuries which interfere with the planned aftercare (intubated for a long time, additional elbow or shoulder fracture)

Design outcomes

Primary

MeasureTime frame
Articular step-off of the distal radius joint surface in the postop CAT-scan6 weeks
Articular gap of the distal radius joint surface in the postop CAT-scan6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026