Clinical trial NCT01612208: MotionLoc Study, Femur Fractures
Official title: Healing of Distal Femur Fractures Stabilized With a Flexible Plating Construct Using MotionLoc Screws
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture of the Distal Femur
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Legacy Health System
First posted: 2012-06-05
Enrollment: 2
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Distal femur fractures (AO/OTA Type 33A and 33C)

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.

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.

Primary outcomes:
measure: Fracture Healing
timeFrame: 6, 12, and 24 weeks post surgery
Secondary outcomes:
measure: Periosteal Callus Size
timeFrame: 6, 12, 24 weeks post surgery
measure: Bridging Callus from CT
timeFrame: 12 weeks post surgery
measure: Fixation Failure
timeFrame: 24 weeks post surgery
measure: Hardware failure
timeFrame: 6, 12, 24 weeks post surgery
Other outcomes:
Locations:
Study officials:
affiliation: Orthopedic Surgery Operations
name: Erik Kubiak
role: PRINCIPAL_INVESTIGATOR
References: