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NCT00644397 · ClinicalTrials.gov registry record
Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options
A clinical trial of Femoral Fractures, sponsored by MetroHealth Medical Center.
- Completed
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT00644397 is a study of Femoral Fractures that has completed, run by MetroHealth Medical Center. The registered enrollment target is 80 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00644397, a study of Femoral Fractures, has completed, sponsored by MetroHealth Medical Center.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
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, categorized as an unspecified phase. 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 76 total studies on file at ClinicalTrials.gov.
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.
NCT00644397 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
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.
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).
Who is sponsoring clinical trial NCT00644397?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
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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