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

• Sponsor: Vilijam Zdravkovic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05739240
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 25

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture; 3D Printing	Procedure: Osteosynthesis	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: no 3D model	Procedure: Osteosynthesis; Osteosynthesis of distal radius fractures
Other: 3D model	Procedure: Osteosynthesis; Osteosynthesis of distal radius fractures

Outcome Measures

Primary Outcome Measures

1. Articular step-off of the distal radius joint surface in the postop CAT-scan [6 weeks]

2. Articular gap of the distal radius joint surface in the postop CAT-scan [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Vilijam Zdravkovic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vilijam Zdravkovic, Principal investigator, Cantonal Hospital of St. Gallen
• ClinicalTrials.gov Identifier: NCT05739240
• Other Study ID Numbers: 22.002
• First Posted: Feb 22, 2023
• Last Update Posted: Mar 1, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fractures, Bone; Radius Fractures

Study Results

No Results Posted as of Mar 1, 2023