- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693367
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
August 11, 2020 updated by: AO Innovation Translation Center
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wien, Austria
- Wilhelminenspital
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Berlin, Germany, 13353
- Charité Berlin, Campus Virchow Klinikum
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Homburg, Germany, 66421
- Universitatsklinikum des Saarlandes
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Tübingen, Germany, 72076
- BGU Tübingen
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Chur, Switzerland, 7000
- Cantonal Hospital Chur
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Luzern, Switzerland, 6000
- Luzerner Kantonsspital
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Zürich, Switzerland, 8091
- Universitatsspital Zurich
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California
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Sacramento, California, United States, 95817
- UC Davis Medical Center
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri Orthopaedics
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Saint Louis, Missouri, United States, 63110
- Washington University Orthopedics
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: DLS 5.0 (Dynamic Locking Screws)
ORIF with DLS 5.0 (Dynamic Locking Screws)
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Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
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ACTIVE_COMPARATOR: SLS (Standard locking screw)
ORIF with SLS (Standard locking screw)
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Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Western Ontario and McMaster Universities Index (WOMAC)
Time Frame: 12 months after surgery
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To assess pain, stiffness, and physical function
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12 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Timed Up-and-go Test (TUG)
Time Frame: 12 weeks ± 7 days, 6 months ± 30 days
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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.
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12 weeks ± 7 days, 6 months ± 30 days
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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
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Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
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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
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Assessment of passive ROM of the knee (flexion - extension)
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6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
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Full Weight-bearing Status
Time Frame: weekly measurement at home
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Assessment of the timepoint when the patient :
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weekly measurement at home
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WOMAC
Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
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To assess pain, stiffness, and physical function
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Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael J. Gardner, MD, Washington University School of Medicine
- Principal Investigator: Sean E. Nork, MD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLS 5.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of WashingtonTerminated
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McGill University Health Centre/Research Institute...Canadian Orthopaedic Trauma SocietyUnknown
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Stryker Trauma GmbHGlobal Research SolutionsCompletedFemoral Neck Fractures | Intertrochanteric FractureUnited States, United Kingdom, Canada, Denmark, Germany, Australia, China, Colombia, Japan, Netherlands, Norway, South Africa
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