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

Phase 4TerminatedNCT01693367

AO Innovation Translation Center5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Distal Femur Fractures

Interventions

DLS 5.0 (Dynamic locking screws)DEVICE

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)DEVICE

Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Western Ontario and McMaster Universities Index (WOMAC)

To assess pain, stiffness, and physical function

Time frame: 12 months after surgery

Secondary Outcomes

Timed Up-and-go Test (TUG)

The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seated position is reached again.

Time frame: 12 weeks ± 7 days, 6 months ± 30 days

Quality of Life (EuroQol-5D)

Time frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery

Range of Motion (ROM)

Assessment of passive ROM of the knee (flexion - extension)

Time frame: 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery

Full Weight-bearing Status

Assessment of the timepoint when the patient : * can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds * can walk without walking aid * has no intake of analgesics * has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable

Time frame: weekly measurement at home

WOMAC

To assess pain, stiffness, and physical function

Time frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery

Data from ClinicalTrials.gov

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