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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2014

Interventions

  • 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
  • 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)

Arms, Groups and Cohorts

  • Active Comparator: DLS 5.0 (Dynamic Locking Screws)
    • ORIF with DLS 5.0 (Dynamic Locking Screws)
  • Active Comparator: SLS (Standard locking screw)
    • ORIF with SLS (Standard locking screw)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Timed Up-and-go Test (TUG)
    • Time Frame: 12 weeks ± 7 days, 6 months ± 30 days
    • 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.
  • 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)
    • Time Frame: 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
    • Assessment of passive ROM of the knee (flexion – extension)
  • Full Weight-bearing Status
    • Time Frame: weekly measurement at home
    • 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
  • WOMAC
    • Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
    • To assess pain, stiffness, and physical function

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AO Innovation Translation Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael J. Gardner, MD, Principal Investigator, Washington University School of Medicine
    • Sean E. Nork, MD, Principal Investigator, University of Washington

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.