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

Primary Purpose

Distal Radius Fracture, 3D Printing

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteosynthesis
Sponsored by
Vilijam Zdravkovic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    no 3D model

    3D model

    Arm Description

    Outcomes

    Primary Outcome Measures

    Articular step-off of the distal radius joint surface in the postop CAT-scan
    Articular gap of the distal radius joint surface in the postop CAT-scan

    Secondary Outcome Measures

    Full Information

    First Posted
    February 12, 2023
    Last Updated
    February 27, 2023
    Sponsor
    Vilijam Zdravkovic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05739240
    Brief Title
    Effects of Preoperative 3D Printing of Distal Intra-articular Radius Fractures on Quality of Fracture Reduction
    Acronym
    3PAS
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    March 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Vilijam Zdravkovic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Distal Radius Fracture, 3D Printing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    no 3D model
    Arm Type
    Other
    Arm Title
    3D model
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    Osteosynthesis
    Intervention Description
    Osteosynthesis of distal radius fractures
    Primary Outcome Measure Information:
    Title
    Articular step-off of the distal radius joint surface in the postop CAT-scan
    Time Frame
    6 weeks
    Title
    Articular gap of the distal radius joint surface in the postop CAT-scan
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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