NCT05739240

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

February 12, 2023

Last Update Submit

February 27, 2023

Conditions

Distal Radius Fracture3D Printing

Outcome Measures

Primary Outcomes (2)

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

    6 weeks

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

    6 weeks

Study Arms (2)

no 3D model

OTHER
Procedure: Osteosynthesis

3D model

OTHER
Procedure: Osteosynthesis

Interventions

OsteosynthesisPROCEDURE

Osteosynthesis of distal radius fractures

3D modelno 3D model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 22, 2023

Study Start

March 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2025

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share