Full Text View
Tabular View
No Study Results Posted
Related Studies
Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options
This study is currently recruiting participants.
Study NCT00644397   Information provided by MetroHealth Medical Center
First Received: March 24, 2008   Last Updated: May 5, 2009   History of Changes

March 24, 2008
May 5, 2009
May 2006
 
 
 
Complete list of historical versions of study NCT00644397 on ClinicalTrials.gov Archive Site
 
 
 
Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options
Plate Fixation of Distal Femur Fractures: a Protocol for a Randomized, Prospective 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 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 problems with infection, nonunion, malunion, or other complications. Because of the study, early and late complication rates and functional outcomes after these treatments may be better defined, allowing for optimization of care of people with these injuries in the future. This should reduce not only direct and indirect costs to the individual, but also costs to society.

 
 
Observational
Case-Only, Prospective
Femoral Fractures
  • Device: 95-degree Angled Blade Plate
  • Device: 4.5mm Condylar Locking Plate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
 
 

Inclusion Criteria:

  • Closed or Gustilo 13,14 Type I, II or IIIA open fractures that can be treated with an angled blade plate or an LCP Condylar Plate (Orthopaedic Trauma Association fracture classification 33-A, 33- C1, 33- C2), (Tables 1 & Figure 3)
  • 16 or more years of age and skeletally-mature, regardless of race or gender

Exclusion Criteria:

  • Pathologic fractures secondary to neoplasm
  • Time elapsed since injury greater than 10 days before fixation
  • Open fractures unable to undergo debridement and irrigation in the first 24 hours
  • Inability or refusal to give consent
Both
16 Years and older
No
Contact: Heather A. Vallier, M.D. 216-778-7644 hvallier@metrohealth.org
Contact: Chalitha N. Robinson, B.A. 216-778-3657 crobinson2@metrohealth.org
United States
 
NCT00644397
Heather A. Vallier, M.D., MetroHealth Medical Center
IRB06-00029
MetroHealth Medical Center
  • Milton S. Hershey Medical Center
  • University of Florida
Principal Investigator: Heather A. Vallier, M.D. MetroHealth Medical Center
Study Director: Chalitha N. Robinson, B.A. MetroHealth Medical Center
MetroHealth Medical Center
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP