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

This study has suspended participant recruitment.
(due to technical issues)
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01693367
First received: September 20, 2012
Last updated: March 18, 2014
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Distal Femur Fractures
Device: DLS 5.0 (Dynamic locking screws)
Device: SLS (Standard locking screw)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Index (WOMAC) [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    To assess pain, stiffness, and physical function


Secondary Outcome Measures:
  • Timed up-and-go test (TUG) [ Time Frame: 12 weeks ± 7 days, 6 months ± 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Assessment of passive ROM of the knee (flexion - extension)

  • Full weight-bearing status [ Time Frame: weekly measurement at home ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    To assess pain, stiffness, and physical function


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693367

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Missouri
University of Missouri Orthopaedics
Columbia, Missouri, United States, 65212
Washington University Orthopedics
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Austria
Wilhelminenspital
Wien, Austria
Germany
Charité Berlin, Campus Virchow Klinikum
Berlin, Germany, 13353
Universitätsklinikum des Saarlandes
Homburg, Germany, 66421
BGU Tübingen
Tübingen, Germany, 72076
Switzerland
Cantonal Hospital Chur
Chur, Switzerland, 7000
Luzerner Kantonsspital
Luzern, Switzerland, 6000
Universitätsspital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Michael J. Gardner, MD Washington University School of Medicine
Principal Investigator: Sean E. Nork, MD University of Washington
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01693367     History of Changes
Other Study ID Numbers: DLS 5.0
Study First Received: September 20, 2012
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission
Switzerland: Ethikkommission
Austria: Ethikkommission

Keywords provided by AO Clinical Investigation and Documentation:
Femoral fracture
Periprosthetic fracture
Fracture fixation, internal
Distal femur fractures
Dynamic Locking Screw
WOMAC

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 23, 2014