Completed

MotionLoc Study: Healing of Distal Femur Fractures Stabilized With a Flexible Plating Construct Using MotionLoc Screws

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Femoral Fractures+2

+ Leg Injuries

+ Wounds and Injuries

Over 17 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2011
See protocol details

Summary

Principal SponsorLegacy Biomechanics Laboratory
Last updated: January 29, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

Rigid locked plating constructs can suppress fracture healing, particularly at the near cortex adjacent to the plate where interfragmentary motion is minimal. Dynamic fixation with Far Cortical Locking (FCL) screws reduces construct stiffness and induces axial interfragmentary motion to stimulate symmetric callus formation and healing. Two versions of FCL screws are commercially available, but the clinical durability of this novel concept has not been documented to date. This prospective observational study documented our early clinical experience with MotionLoc® FCL screws for stabilization of distal femur fractures to assess their durability and potential complications. Thirty-two consecutive patients with 33 distal femur fractures (AO/OTA types 33-A and 33-C) were prospectively enrolled at three trauma centers. Fractures were stabilized by plate osteosynthesis with MotionLoc® FCL screws without supplemental bone graft or bone morphogenic proteins. Thirty patients with 31 fractures were available for follow-up until union or revision. Follow-up visits at 6, 12, and 24 weeks comprised functional and radiographic assessment of implant fixation and fracture healing, including computed tomography scans at week 12. The primary endpoint was fracture healing in absence of complications and revision. There was no incidence of implant breakage or diaphyseal fixation failure. Thirty of 31 fractures healed within 15.6 ± 6.2 weeks, as evident by bridging callus and pain-free load bearing. There were two revisions, one at 5 days post surgery to correct a mal-rotation, and one at 6 months post surgery to revise a non-union. Periosteal callus distribution at week 6 was symmetrical, with similar amounts of callus at the medial cortex (35%) anterior cortex (30%) and posterior cortex (35%). In 23 fractures (74%), callus formation extended to the lateral cortex under the plate. Absence of hardware and fixation failure suggests that dynamic plating of distal femur fractures with FCL screws provides safe and effective fixation. Moreover, the amount and symmetric distribution of periosteal callus suggests that dynamic fixation with FCL screws may promote increased fracture healing over standard locked plating. However, this hypothesis on the stimulatory effect of dynamic fixation on fracture healing requires investigation in a future randomized control trial.

Principal SponsorLegacy Biomechanics Laboratory
Last updated: January 29, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Femoral FracturesLeg InjuriesWounds and InjuriesFractures, BoneFemoral Fractures, Distal

Criteria

3 inclusion criteria required to participate
Patients 17 years of age and over

Patients able to be operated on by selected surgeons at the participating centers

Patients with distal femur fracture (AO/OTA Type 33A and 33C)

10 exclusion criteria prevent from participating
Acute or chronic local or systemic infections

Considered an inappropriate participant by the study physician

Fracture fixed more then 28 days after injury

Patients currently incarcerated or awaiting incarceration

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Legacy Health System

Portland, United StatesOpen Legacy Health System in Google Maps
CompletedOne Study Center