Fracture of the Distal FemurNCT01612208
MotionLoc Study, Femur Fractures
An observational study of Fracture of the Distal Femur, run by University of Utah.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Fracture of the Distal Femur
- What is being tested?
- Periarticular Locking Plate (NCB, Zimmer) and MotionLoc Screw
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Distal femur fractures (AO/OTA Type 33A and 33C)
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Healing of Distal Femur Fractures Stabilized With a Flexible Plating Construct Using MotionLoc Screws
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.
Read the 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.
- Conditions
- Fracture of the Distal Femur
- Being tested
- Periarticular Locking Plate (NCB, Zimmer), MotionLoc Screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periarticular Locking Plate (NCB, Zimmer)Device
The proximal plate segment will be applied to the diaphysis using four 5.0 mm MotionLoc screws. The plate will not be compressed onto the femoral diaphysis to preserve periosteal perfusion and to enable controlled motion between the plate and the diaphysis. If desirable, temporary spacers of the NCB set may be used in the proximal plate segment to facilitate 1-2 mm plate elevation over the diaphysis. Only MotionLoc screws will be used for fixation of the NCB plate proximal to the fracture site.
MotionLoc ScrewDevice
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These MotionLoc screws have a reduced 3.4 mm diameter mid-shaft section to bypass the near cortex. By avoiding rigid constraint in the near cortex, the MotionLoc screw design increases the working length of the screw, allowing for elastic flexion of the screw shaft within a controlled motion envelope in the near cortex.
| Study group | Role | What they receive |
|---|---|---|
| Distal femur fractures | (AO/OTA types 33-A and 33-C) Receives: Device: Periarticular Locking Plate (NCB, Zimmer); Device: MotionLoc Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture Healing
Fracture healing is defined clinically by the ability of pain-free weight bearing, and radiographically by callus formation and bridging.
Measured: 6, 12, and 24 weeks post surgery
Secondary outcomes (4)
Periosteal Callus Size
Periosteal callus size is assessed at the anterior, posterior, and medial aspects on radiographs using a validated computational algorithm.
Measured: 6, 12, 24 weeks post surgery
Bridging Callus from CT
Cross-sectional image analysis, supported by 3-D rendering, to detect bony bridging at the anterior, posterior, and lateral aspects of the femur.
Measured: 12 weeks post surgery
Fixation Failure
Assessed in terms of loss of alignment at 12 and 24 weeks post surgery
Measured: 24 weeks post surgery
Hardware failure
Breakage of screw or plate
Measured: 6, 12, 24 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startApr 2011
- Primary completionMay 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of the Distal FemurStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Legacy Health System
- Responsible party
- Principal investigator, Eric Kubiak, University of Utah
- Investigators
- Erik Kubiak, Principal investigator, Orthopedic Surgery Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612208
- Sponsor's protocol ID
- 51842
- Status last verified
- May 2014
- First submitted
- 31 May 2012
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing of Distal Femur Fractures Stabilized With a Flexible Plating Construct Using MotionLoc Screws
- ClinicalTrials.gov ID
- NCT01612208
- Acronym / sponsor ID
- 51842
- Conditions
- Fracture of the Distal Femur
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Legacy Health System
- Study start
- Apr 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal femur fractures | – | Device: Periarticular Locking Plate (NCB, Zimmer), Device: MotionLoc Screw(AO/OTA types 33-A and 33-C) |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Distal femur fractures (AO/OTA Type 33A and 33C)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periarticular Locking Plate (NCB, Zimmer)The proximal plate segment will be applied to the diaphysis using four 5.0 mm MotionLoc screws. The plate will not be compressed onto the femoral diaphysis to preserve periosteal perfusion and to enable controlled motion between the plate and the diaphysis. If desirable, temporary spacers of the NCB set may be used in the proximal plate segment to facilitate 1-2 mm plate elevation over the diaphysis. Only MotionLoc screws will be used for fixation of the NCB plate proximal to the fracture site. | Device | Distal femur fractures |
| MotionLoc ScrewThe NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These MotionLoc screws have a reduced 3.4 mm diameter mid-shaft section to bypass the near cortex. By avoiding rigid constraint in the near cortex, the MotionLoc screw design increases the working length of the screw, allowing for elastic flexion of the screw shaft within a controlled motion envelope in the near cortex. | Device | Distal femur fractures |
Primary outcome
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.
4 secondary outcomes
Periosteal Callus Size
Time frame: 6, 12, 24 weeks post surgery
Bridging Callus from CT
Time frame: 12 weeks post surgery
Fixation Failure
Time frame: 24 weeks post surgery
Hardware failure
Time frame: 6, 12, 24 weeks post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Kubiak principal investigator
Orthopedic Surgery Operations
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of the Distal Femur, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture Healing (time frame: 6, 12, and 24 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.