Clinical trial NCT01693367: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Distal Femur Fractures
Keywords: Femoral fracture
Periprosthetic fracture
Fracture fixation, internal
Distal femur fractures
Dynamic Locking Screw
WOMAC
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Western Ontario and McMaster Universities Index (WOMAC)
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Timed Up-and-go Test (TUG)
timeFrame: 12 weeks ± 7 days, 6 months ± 30 days
measure: Quality of Life (EuroQol-5D)
timeFrame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
measure: Range of Motion (ROM)
timeFrame: 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
measure: Full Weight-bearing Status
timeFrame: weekly measurement at home
measure: WOMAC
timeFrame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Columbia
country: United States
facility: University of Missouri Orthopaedics
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Orthopedics
state: Missouri
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Wien
country: Austria
facility: Wilhelminenspital
city: Berlin
country: Germany
facility: Charité Berlin, Campus Virchow Klinikum
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Tübingen
country: Germany
facility: BGU Tübingen
city: Chur
country: Switzerland
facility: Cantonal Hospital Chur
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Washington University School of Medicine
name: Michael J. Gardner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Sean E. Nork, MD
role: PRINCIPAL_INVESTIGATOR
References: