3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care
NCT ID: NCT05741892
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2023-04-01
2025-12-01
Brief Summary
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Detailed Description
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The most frequent postoperative deformity in long bone shaft fractures is malrotation. In femoral fractures, clinically relevant rotational errors (\>15°) occur in up to 40% of cases after surgical treatment, which either results in a poor clinical outcome or requires revision surgery. In tibial diaphyseal fractures, up to 50% of rotational errors have been reported. The higher the degree of comminution the higher the chances of malrotation postoperatively. Due to the comminuted situation, no reliable bony references exist intraoperatively and the surgeon can only estimate the correct length, axis and, rotation based on the contralateral leg. This ultimately leads to a high number of revision surgeries or poor outcomes. Porcine and human cadaveric feasibility studies conducted by the study team utilizing site 3D planned and printed reduction guides showed excellent accuracy of fracture reduction.
This project aims to apply this technique to the clinical setting by conducting a clinical study. The accuracy of 3D planned surgery performed with surgical guides designed and printed at the point of care will be assessed and the complication rate will be compared to the known literature.
It was hypothesized that the mean deviation between the measured postoperative rotational alignment and planned rotation alignment in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 5°. Additionally, it was hypothesized that the rate of clinically relevant deviations between postoperative rotational alignment (e.g. 15°) and planned rotation in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 10%.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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3D fracture reposition guide group
Comminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides.
Fracture reposition with 3D printed patient specific repositions guides
Comminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides.
Interventions
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Fracture reposition with 3D printed patient specific repositions guides
Comminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Abnormal contralateral bony anatomy (previous surgeries, poliomyelitis, previous injury, implants)
* Pregnancy
* Acute tumor or previous tumor disease
* Acute infection
18 Years
99 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Hecker Andreas, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik für Orthopädische Chirurgie und Traumatologie
Locations
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Universitätsklinik für Orthopädische Chirurgie und Traumatologie
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Andreas Hecker, MD
Role: primary
Other Identifiers
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5364
Identifier Type: -
Identifier Source: org_study_id