Plating of Distal Femur Fractures by Far Cortical Locking Using MotionLoc Screws

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

MotionLoc Study, Femur Fractures

NCT01612208

Fracture of the Distal Femur

COMPLETED

Zimmer® MotionLoc® in Distal Tibia Fractures

NCT02717546

Distal Tibia Fractures

COMPLETED

Locking Plates for Distal Femur Fractures - a Multicenter Case Review

NCT04008940

Distal Femur Fracture

COMPLETED

Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options

NCT00644397

Femoral Fractures

COMPLETED

Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures

NCT01766648

Distal Femur Fracture

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fracture of Distal Femur

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Femur Fractures

Patients with Distal Femur Fractures

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Pregnancy
2. Patients who are enrolled in an investigational treatment trial.
3. Patients who are not expected to survive the follow-up period.
4. Considered an inappropriate participant by the study physician.
5. Revision surgery
6. Patients currently incarcerated or awaiting incarceration.
7. Severe spinal injury with neurological deficit resulting in paralysis.
8. Fracture fixed more then 28 days after injury.
9. Acute or chronic local or systemic infections
10. Periprosthetic fractures

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No