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Clinical Trials/NCT01612208
NCT01612208
Completed
Not Applicable

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

University of Utah0 sites2 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture of the Distal Femur
Sponsor
University of Utah
Enrollment
2
Primary Endpoint
Fracture Healing
Status
Completed
Last Updated
11 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
January 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Kubiak

M.D.

University of Utah

Eligibility Criteria

Inclusion Criteria

  • Patients with distal femur fracture (AO/OTA Type 33A and 33C).
  • Patients 17 years of age and older.
  • Patients able to be operated on by selected surgeons at the participating centers.

Exclusion Criteria

  • 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 28 days after injury.
  • Acute or chronic of systematic infections
  • Patients with periprosthetic fractures.

Outcomes

Primary Outcomes

Fracture Healing

Time Frame: 6, 12, and 24 weeks post surgery

Fracture healing is defined clinically by the ability of pain-free weight bearing, and radiographically by callus formation and bridging.

Secondary Outcomes

  • 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)

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