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Clinical Trials/NCT05739240
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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
March 31, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vilijam Zdravkovic
Responsible Party
Sponsor Investigator
Principal Investigator

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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