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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: AO Clinical Investigation and Documentation

Current Primary Outcome: Western Ontario and McMaster Universities Index (WOMAC) [ Time Frame: 12 months after surgery ]

To assess pain, stiffness, and physical function


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • 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 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


Information By: AO Clinical Investigation and Documentation

Dates:
Date Received: September 20, 2012
Date Started: September 2012
Date Completion:
Last Updated: August 4, 2016
Last Verified: August 2016