MotionLoc Study, Femur Fractures - Full Text View

Purpose

The objective of this multi-center prospective observational study is to document callus formation and healing in fractures stabilized with locking plates utilizing MotionLoc screws. MotionLoc screws are designed to be used with the Zimmer NCB periarticular plating system and have been cleared by the FDA (clearance #K101696) for marketing and use for stabilization of distal femur fractures as proposed in the present study. Thirty-three consecutive patients with distal femur fractures will receive surgical stabilization of their fractures using the NCB distal femoral plate with MotionLoc screws in the diaphysis and standard screws in the metaphysis. Ten patients will participate from the University of Utah.

The surgeon will determine whether use of the MotionLoc screws are appropriate for fixation of the patient's fracture. If the device is appropriate and the surgeons' preference for usage, the patient will be approached for participation in the study. The study is limited to collection of demographic and surgical data, subjective patient questionnaire responses collected at the time of the patient's Standard of Care clinic visits, and a CT scan at twelve weeks post-operation. The CT scan is for study purposes, and will be paid for by the study The primary outcome of interest is the presence or absence of fracture union without secondary intervention. Fracture union will be defined clinically as the ability to bear weight without pain and biomechanically as the presence of callus bridging the fracture.

Condition	Intervention
Facture Healing	Device: Periarticular Locking Plate (NCB, Zimmer) Device: MotionLoc Screw

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Healing of Distal Femur Fractures Stabilized With a Flexible Plating Construct Using MotionLoc Screws

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Comparison of fracture healing with Motionloc screws relative to historic control data with identical outcome parameters on locked plating without Motionloc screws. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Documentation of fracture healing with Motionloc screws [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	8
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Intervention Details:

The proximal plate segment will be applied to the diaphysis using four 5.0 mm MotionLoc screws. The plate will not be compressed onto the femoral diaphysis to preserve periosteal perfusion and to enable controlled motion between the plate and the diaphysis. If desirable, temporary spacers of the NCB set may be used in the proximal plate segment to facilitate 1-2 mm plate elevation over the diaphysis. Only MotionLoc screws will be used for fixation of the NCB plate proximal to the fracture site.

The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These MotionLoc screws have a reduced 3.4 mm diameter mid-shaft section to bypass the near cortex (Figure 2b). By avoiding rigid constraint in the near cortex, the MotionLoc screw design increases the working length of the screw, allowing for elastic flexion of the screw shaft within a controlled motion envelope in the near cortex.

Detailed Description:

This is a multi-center prospective observational clinical study. It is designed to document healing of distal femur fractures that are stabilized with a locking plate using MotionLoc screws. Thirty-three consecutive patients with distal femur fractures will receive surgical stabilization of their fractures using the NCB distal femoral plate with MotionLoc screws in the diaphysis and standard locked screws in the metaphysis.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with distal femur fracture (AO/OTA Type 33A and 33C).
Patients 21 to 80 years of age.
Patients able to be operated on by selected surgeons at the participating centers.

Exclusion Criteria: Exclusion criteria for our participant population will be the following:

Pregnancy
Patients who are enrolled in an investigational treatment trial.
Patients who are not expected to survive the follow-up period.
Considered an inappropriate participant by the study physician.
Revision surgery.
Patients currently incarcerated or awaiting incarceration.
Severe spinal injury with neurological deficit resulting in paralysis.
Fracture fixed more than 14 days after injury.

Patients with periprosthetic fractures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612208

Sponsors and Collaborators

University of Utah

Legacy Health System

Investigators

Principal Investigator:

Erik Kubiak

Orthopedic Surgery Operations

More Information

No publications provided

Responsible Party:	University of Utah
ClinicalTrials.gov Identifier:	NCT01612208 History of Changes
Other Study ID Numbers:	51842
Study First Received:	May 31, 2012
Last Updated:	May 11, 2013
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Additional relevant MeSH terms:

Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 21, 2013