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NCT05739240 Clinical Trial

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

Distal Radius Fracture Clinical Trial

— 3PAS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05739240
Other study ID # 22.002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date March 31, 2025

Study information
Verified date February 2023
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date March 31, 2025
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Osteosynthesis
Osteosynthesis of distal radius fractures

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Vilijam Zdravkovic

Outcome
Type Measure Description Time frame Safety issue
Primary Articular step-off of the distal radius joint surface in the postop CAT-scan 6 weeks
Primary Articular gap of the distal radius joint surface in the postop CAT-scan 6 weeks
See also
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Completed NCT05623865 - The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures. N/A