Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
NCT ID: NCT01693367
Last Updated: 2020-08-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
5 participants
INTERVENTIONAL
2012-09-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DLS 5.0 (Dynamic Locking Screws)
ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws)
Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
SLS (Standard locking screw)
ORIF with SLS (Standard locking screw)
SLS (Standard locking screw)
Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
Interventions
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DLS 5.0 (Dynamic locking screws)
Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
SLS (Standard locking screw)
Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
Eligibility Criteria
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Inclusion Criteria
* Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty
* Ability to walk independently prior to injury
* Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP)
* Willing and able to comply with post-operative protocol and return for follow-up.
* Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation
* Signed informed consent
Exclusion Criteria
* Any kind of implant at the ipsilateral proximal femur
* Pre-existing malunion or nonunion of the ipsilateral lower extremity
* Segmental bone defect requiring bone grafting
* More than 4 weeks between injury and surgery
* Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
* Polytrauma
* Active malignancy
* Any not medically managed severe systemic disease
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the study period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
21 Years
120 Years
ALL
No
Sponsors
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AO Innovation Translation Center
OTHER
Responsible Party
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Principal Investigators
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Michael J. Gardner, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Sean E. Nork, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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UC Davis Medical Center
Sacramento, California, United States
University of Missouri Orthopaedics
Columbia, Missouri, United States
Washington University Orthopedics
St Louis, Missouri, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Harborview Medical Center
Seattle, Washington, United States
Wilhelminenspital
Vienna, , Austria
Charité Berlin, Campus Virchow Klinikum
Berlin, , Germany
Universitätsklinikum des Saarlandes
Homburg, , Germany
BGU Tübingen
Tübingen, , Germany
Cantonal Hospital Chur
Chur, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Countries
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Other Identifiers
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DLS 5.0
Identifier Type: -
Identifier Source: org_study_id
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