NCT05739240
Not Yet Recruiting
N/A
Effects of Preoperative 3D Printing of Distal Intra-articular Radius Fractures on Quality of Fracture Reduction: a Randomized, Single-blinded, Monocentric Clinical Trial
Vilijam Zdravkovic0 sites80 target enrollmentMarch 1, 2023
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Distal Radius Fracture
- Sponsor
- Vilijam Zdravkovic
- Enrollment
- 80
- Primary Endpoint
- Articular gap of the distal radius joint surface in the postop CAT-scan
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Vilijam Zdravkovic
Principal investigator
Cantonal Hospital of St. Gallen
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Articular gap of the distal radius joint surface in the postop CAT-scan
Time Frame: 6 weeks
Articular step-off of the distal radius joint surface in the postop CAT-scan
Time Frame: 6 weeks
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