- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00644397
Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options
August 12, 2019 updated by: Heather A. Vallier, MetroHealth Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participating research centers will evaluate for enrollment all patients presenting with distal femur fractures.
The number of patients to be recruited is based on previously reported malunion rates.
Assuming a 15% incidence of malunion in the locked plating group, a difference of +/- 5% would be statistically significant.
In order for the study to have power of 80% to detect a difference at the 0.05 level, 49 patients will be required in each group.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Blade Plate Group
95-degree Angled Blade Plate
|
|
Locking Plate Group
4.5mm Condylar Locking Plate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heather A. Vallier, M.D., MetroHealth Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (ACTUAL)
January 1, 2018
Study Completion (ACTUAL)
January 1, 2019
Study Registration Dates
First Submitted
March 24, 2008
First Submitted That Met QC Criteria
March 25, 2008
First Posted (ESTIMATE)
March 26, 2008
Study Record Updates
Last Update Posted (ACTUAL)
August 13, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB06-00029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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