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

Primary Purpose

Distal Femur Fractures

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
DLS 5.0 (Dynamic locking screws)
SLS (Standard locking screw)
Sponsored by
AO Innovation Translation Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Femur Fractures focused on measuring Femoral fracture, Periprosthetic fracture, Fracture fixation, internal, Distal femur fractures, Dynamic Locking Screw, WOMAC

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical Center
  • University of Missouri Orthopaedics
  • Washington University Orthopedics
  • Hospital of the University of Pennsylvania
  • Harborview Medical Center
  • Wilhelminenspital
  • Charité Berlin, Campus Virchow Klinikum
  • Universitätsklinikum des Saarlandes
  • BGU Tübingen
  • Cantonal Hospital Chur
  • Luzerner Kantonsspital
  • Universitätsspital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DLS 5.0 (Dynamic Locking Screws)

SLS (Standard locking screw)

Arm Description

ORIF with DLS 5.0 (Dynamic Locking Screws)

ORIF with SLS (Standard locking screw)

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Index (WOMAC)
To assess pain, stiffness, and physical function

Secondary Outcome Measures

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.
Quality of Life (EuroQol-5D)
Range of Motion (ROM)
Assessment of passive ROM of the knee (flexion - extension)
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
WOMAC
To assess pain, stiffness, and physical function

Full Information

First Posted
September 20, 2012
Last Updated
August 11, 2020
Sponsor
AO Innovation Translation Center
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1. Study Identification

Unique Protocol Identification Number
NCT01693367
Brief Title
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
The medical device has been withdrawn from the market due to technical issues.
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Innovation Translation Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Femur Fractures
Keywords
Femoral fracture, Periprosthetic fracture, Fracture fixation, internal, Distal femur fractures, Dynamic Locking Screw, WOMAC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DLS 5.0 (Dynamic Locking Screws)
Arm Type
Active Comparator
Arm Description
ORIF with DLS 5.0 (Dynamic Locking Screws)
Arm Title
SLS (Standard locking screw)
Arm Type
Active Comparator
Arm Description
ORIF with SLS (Standard locking screw)
Intervention Type
Device
Intervention Name(s)
DLS 5.0 (Dynamic locking screws)
Intervention Description
Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
Intervention Type
Device
Intervention Name(s)
SLS (Standard locking screw)
Intervention Description
Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Index (WOMAC)
Description
To assess pain, stiffness, and physical function
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Timed Up-and-go Test (TUG)
Description
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
Title
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
Title
Range of Motion (ROM)
Description
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
Title
Full Weight-bearing Status
Description
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
Title
WOMAC
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Gardner, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean E. Nork, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Missouri Orthopaedics
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Washington University Orthopedics
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Wilhelminenspital
City
Wien
Country
Austria
Facility Name
Charité Berlin, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
BGU Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Cantonal Hospital Chur
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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