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

AO Innovation Translation Center

Status and phase: Terminated; Phase 4

Conditions: Distal Femur Fractures

Treatments: Device: SLS (Standard locking screw); Device: DLS 5.0 (Dynamic locking screws)

Study type: Interventional

Funder types: Other

Identifiers

NCT01693367

DLS 5.0

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 21 to 120 years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups

DLS 5.0 (Dynamic Locking Screws)

Active Comparator group

Description:

ORIF with DLS 5.0 (Dynamic Locking Screws)

Treatment:

Device: DLS 5.0 (Dynamic locking screws)

SLS (Standard locking screw)

Active Comparator group

Description:

ORIF with SLS (Standard locking screw)

Treatment:

Device: SLS (Standard locking screw)