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

Distal Femur Fractures Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01693367
• Other study ID #: DLS 5.0
• Status: Terminated
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Femur Fractures
• Femoral Fractures
• Fractures, Bone

Intervention

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
• 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)

Locations

Country	Name	City	State
Austria	Wilhelminenspital	Wien
Germany	Charité Berlin, Campus Virchow Klinikum	Berlin
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	BGU Tübingen	Tübingen
Switzerland	Cantonal Hospital Chur	Chur
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Universitätsspital Zürich	Zürich
United States	University of Missouri Orthopaedics	Columbia	Missouri
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	UC Davis Medical Center	Sacramento	California
United States	Washington University Orthopedics	Saint Louis	Missouri
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Index (WOMAC)	To assess pain, stiffness, and physical function	12 months after surgery
Secondary	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.	12 weeks ± 7 days, 6 months ± 30 days
Secondary	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
Secondary	Range of Motion (ROM)	Assessment of passive ROM of the knee (flexion - extension)	6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Secondary	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	weekly measurement at home
Secondary	WOMAC	To assess pain, stiffness, and physical function	Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery