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Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options
NCT00644397 · View on ClinicalTrials.gov ↗
Study Summary
Internal fixation of femur fractures improves alignment and provides stability to the bone and the surrounding soft tissues. This generally allows for early motion of the adjacent joints; thus maximizing overall function of the limb. Open reduction and internal fixation with plates and screws is the standard method that has been used in the treatment of distal femoral fractures. One common traditional method of internal fixation is the 95-degree angled blade plate. Recent advances in technology for distal femur fractures include the LCP™ Condylar Plate. This implant differs from the blade plate, because the LCP offers multiple points of fixed angle contact between the plate and screws in the distal femur. The introduction of plates with the option of locked screws has provided means to increase the rigidity of fixation in osteoporotic bone or in periarticular fractures with a small distal segment, and the LCP may be technically easier to apply than the blade plate. To the investigators' knowledge, there have been no published clinical or biomechanical studies specific to the LCP Condylar Plate, although the early results of LCP implants for other fractures are promising. The investigators believe that locked plating represents a valuable advancement in fracture treatment. However, the limitations of this new technology and the indications for its use have not been completely elucidated. Furthermore, the cost of the new technology is approximately seven times more than the traditional treatment. This is a randomized, prospective, multi-center study to compare the blade plate and the LCP in the distal femur. All patients 16 years of age or older, regardless of race or gender, with a supracondylar fracture of distal femur will be considered. Whether patients are treated with a blade plate or/and LCP, they will be receiving standard orthopedic care for their injury. Neither of these methods currently places a patient at increased surgical or post-surgical risk for probl
Conditions Studied
Interventions
- DEVICE 95-degree Angled Blade Plate
- DEVICE 4.5mm Condylar Locking Plate
Study Locations (1)
Ohio
- MetroHealth Medical Center — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2006-05 |
| Est. Completion | 2019-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00644397
The ClinicalTrials.gov registry entry for NCT00644397 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Femoral Fractures appearing as the primary indexed condition, and to 2 interventions — of which 95-degree Angled Blade Plate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00644397 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00644397 about?
NCT00644397 is a clinical study titled "Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options". Internal fixation of femur fractures improves alignment and provides stability to the bone and the surrounding soft tissues. This generally allows for early motion of the adjacent joints; thus maximizing overall function of the limb. Open reduction and internal fixation with plates and screws is the...
What is the current status of trial NCT00644397?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2006-05. Estimated completion is 2019-01.
What conditions does trial NCT00644397 study?
This clinical trial studies the following conditions: Femoral Fractures. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00644397?
The interventions under investigation include: 95-degree Angled Blade Plate (DEVICE), 4.5mm Condylar Locking Plate (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00644397?
This trial is sponsored by MetroHealth Medical Center, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00644397 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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