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



Status:Terminated
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - 120
Updated:4/21/2016
Start Date:September 2012
End Date:December 2014

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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

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.


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

- 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
We found this trial at
6
sites
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Seattle, WA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Sacramento, California 95814
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Sacramento, CA
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Columbia, Missouri 65212
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Columbia, MO
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St. Louis, Missouri 63110
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St. Louis, MO
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Wien,
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