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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
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