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

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 Overview

• Status: Terminated
• Conditions: Distal Femur Fractures
• Intervention / Treatment: Device: DLS 5.0 (Dynamic locking screws); Device: SLS (Standard locking screw)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • Wilhelminenspital
• Germany
  • Berlin, Germany, 13353
    • Charité Berlin, Campus Virchow Klinikum
  • Homburg, Germany, 66421
    • Universitatsklinikum des Saarlandes
  • Tübingen, Germany, 72076
    • BGU Tübingen
• Switzerland
  • Chur, Switzerland, 7000
    • Cantonal Hospital Chur
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich
• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Orthopaedics
    • Saint Louis, Missouri, United States, 63110
      • Washington University Orthopedics
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: DLS 5.0 (Dynamic Locking Screws); ORIF with DLS 5.0 (Dynamic Locking Screws)	Device: 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
ACTIVE_COMPARATOR: SLS (Standard locking screw); ORIF with SLS (Standard locking screw)	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Index (WOMAC)	To assess pain, stiffness, and physical function	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks ± 7 days, 6 months ± 30 days
Quality of Life (EuroQol-5D)		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)	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	weekly measurement at home
WOMAC	To assess pain, stiffness, and physical function	Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Michael J. Gardner, MD, Washington University School of Medicine; Principal Investigator: Sean E. Nork, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (ESTIMATE): September 26, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: WOMAC; Periprosthetic fracture; Femoral fracture; Fracture fixation, internal; Distal femur fractures; Dynamic Locking Screw
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: DLS 5.0