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Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation | Clinical Trials | Clareo Health

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Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation

A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation

NCT01693367•AO Innovation Translation Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.

Eligibility

Age

21 - 120 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•21 years and older
•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

•Additional ipsi- or contralateral lower extremity fracture
•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
+3 more criteria

Locations (12)

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

Key Dates

Start Date

September 1, 2012

Primary Completion Date

December 1, 2014

Completion Date

December 1, 2014

Last Updated

August 13, 2020

Enrollment

ACTUAL participants

Conditions

Distal Femur Fractures

Interventions

DLS 5.0 (Dynamic locking screws)

DEVICE

SLS (Standard locking screw)

DEVICE