3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care
3DFRG
1 other identifier
interventional
15
1 country
1
Brief Summary
The aim of the study is to assess the accuracy of fracture reduction performed with surgical guides designed and 3D printed at the point of care in comminuted fractures of femur- and tibia-shaft.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 6, 2023
December 1, 2023
1.7 years
February 13, 2023
December 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rotational deviation (Axial plane deviation) in degree
Planned rotational alignment versus postoperative rotational alignment.
Between 1 to 7 days postoperative, depending on the patients status
Secondary Outcomes (3)
Length deviation in mm
Between 1 to 7 days postoperative, depending on the patients status
Frontal plane deviation in degree
Between 1 to 7 days postoperative, depending on the patients status
Sagittal plane deviation in degree
Between 1 to 7 days postoperative, depending on the patients status
Study Arms (1)
3D fracture reposition guide group
EXPERIMENTALComminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides.
Interventions
Comminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides.
Eligibility Criteria
You may qualify if:
- Age between 18 and 99 years
- Comminuted shaft fracture of tibia or femur
- Intact contralateral tibia or femur
- Patient willing to participate and sign the informed consent
- Clear indication of surgical treatment
You may not qualify if:
- Refusal to sign the informed consent
- Abnormal contralateral bony anatomy (previous surgeries, poliomyelitis, previous injury, implants)
- Pregnancy
- Acute tumor or previous tumor disease
- Acute infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinik für Orthopädische Chirurgie und Traumatologie
Bern, 3010, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hecker Andreas, MD
Universitätsklinik für Orthopädische Chirurgie und Traumatologie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2023
First Posted
February 23, 2023
Study Start
April 1, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
December 6, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share