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

NCT01693367 | Terminated Phase 4 Results

• 1 other identifier: DLS 5.0
• Study Type: interventional
• Target: 5
• Locations: 4 countries
• Sites: 12

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.

Conditions

Distal Femur Fractures

Keywords

Femoral fracture; Periprosthetic fracture; Fracture fixation, internal; Distal femur fractures; Dynamic Locking Screw; WOMAC

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Index (WOMAC)

  To assess pain, stiffness, and physical function

  12 months after surgery

Secondary Outcomes (5)

• Timed Up-and-go Test (TUG)

  12 weeks ± 7 days, 6 months ± 30 days

• Quality of Life (EuroQol-5D)

  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)

  6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery

• Full Weight-bearing Status

  weekly measurement at home

• WOMAC

  Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery

Study Arms (2)

DLS 5.0 (Dynamic Locking Screws)

ACTIVE COMPARATOR

ORIF with DLS 5.0 (Dynamic Locking Screws)

Device: DLS 5.0 (Dynamic locking screws)

SLS (Standard locking screw)

ACTIVE COMPARATOR

ORIF with SLS (Standard locking screw)

Device: SLS (Standard locking screw)

Interventions

DLS 5.0 (Dynamic locking screws) DEVICE

Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0

DLS 5.0 (Dynamic Locking Screws)

SLS (Standard locking screw) DEVICE

Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)

SLS (Standard locking screw)

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (12)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

University of Missouri Orthopaedics

Columbia, Missouri, 65212, United States

Location

Washington University Orthopedics

St Louis, Missouri, 63110, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Wilhelminenspital

Vienna, Austria

Location

Charité Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

BGU Tübingen

Tübingen, 72076, Germany

Location

Cantonal Hospital Chur

Chur, 7000, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Femoral Fractures, Distal; Femoral Fractures; Periprosthetic Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Results Point of Contact

• Title: Clinical Operations Manager of Clinical Investigation and Documentation
• Organization: AO Foundation

andreas.faeh@aofoundation.org

0041 44 200 24 67

Study Officials

• Michael J. Gardner, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Sean E. Nork, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 13, 2020
• Results First Posted: July 1, 2016

Record last verified: 2016-08

Locations

DE (3); CH (3); US (5); AU (1)