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

Not Applicable

Not yet recruiting

• Conditions: 3D Printing; Distal Radius Fracture
• Interventions: Procedure: Osteosynthesis

• Registration Number: NCT05739240
• Lead Sponsor: Vilijam Zdravkovic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-12
• Study First Posted: 2023-02-22
• Last Update Submitted: 2023-02-27
• Study Start: 2023-03-01
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no 3D model	Osteosynthesis	-
3D model	Osteosynthesis	-

Primary Outcome Measures

Name	Time	Method
Articular gap of the distal radius joint surface in the postop CAT-scan	6 weeks
Articular step-off of the distal radius joint surface in the postop CAT-scan	6 weeks