Plating of Distal Femur Fractures by Far Cortical Locking Using MotionLoc Screws
MotionLoc Study: Healing of Distal Femur Fractures Stabilized With a Flexible Plating Construct Using MotionLoc Screws
1 other identifier
observational
33
1 country
1
Brief Summary
The objective of this study is to document callus formation and healing of fractures stabilized with locking plates utilizing modern MotionLoc screws that provide controlled axial micro-motion to actively promote fracture healing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJanuary 29, 2013
January 1, 2013
1.1 years
August 15, 2012
January 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fracture Healing
Fracture healing is defined clinically by the ability of pain-free weight bearing, and radiographically by callus formation and bridging.
6, 12, and 24 weeks post surgery
Secondary Outcomes (4)
Periosteal Callus Size
6, 12, 24 weeks post surgery
Bridging Callus from CT
12 weeks post surgery
Fixation Failure
24 weeks post surgery
Hardware failure
6, 12, 24 weeks post surgery
Study Arms (1)
Femur Fractures
Patients with Distal Femur Fractures
Eligibility Criteria
Distal femur fractures (AO/OTA Type 33A and 33C)
You may qualify if:
- Patients with distal femur fracture (AO/OTA Type 33A and 33C)
- Patients 17 years of age and over.
- Patients able to be operated on by selected surgeons at the participating centers.
You may not qualify if:
- 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 then 28 days after injury.
- Acute or chronic local or systemic infections
- Periprosthetic fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Legacy Biomechanics Laboratorylead
- Slocum Center for Orthopedics and Sports Medicinecollaborator
- University of Utahcollaborator
- Zimmer Biometcollaborator
Study Sites (1)
Legacy Health System
Portland, Oregon, 97232, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bottlang, PhD
Legacy Biomechanics Laboratory
- STUDY CHAIR
Steven Madey, MD
Legacy Health System
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Legacy Biomechanics Laboratory
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 17, 2012
Study Start
April 1, 2011
Primary Completion
May 1, 2012
Study Completion
January 1, 2013
Last Updated
January 29, 2013
Record last verified: 2013-01