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Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options

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ClinicalTrials.gov Identifier: NCT00644397
Recruitment Status : Recruiting
First Posted : March 26, 2008
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 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.

Condition or disease Intervention/treatment
Femoral Fractures Device: 95-degree Angled Blade Plate Device: 4.5mm Condylar Locking Plate

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Plate Fixation of Distal Femur Fractures: a Protocol for a Randomized, Prospective Study of Two Plate Options
Study Start Date : May 2006
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Blade Plate Group
95-degree Angled Blade Plate
Device: 95-degree Angled Blade Plate
Locking Plate Group
4.5mm Condylar Locking Plate
Device: 4.5mm Condylar Locking Plate


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644397


Contacts
Contact: Heather A. Vallier, M.D. 216-778-7434 hvallier@metrohealth.org
Contact: Mary A Breslin, B.A. 216-778-3656 mbreslin@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Mary A Breslin, B.A.    216-778-3656    mbreslin@metrohealth.org   
Principal Investigator: Heather A. Vallier, M.D.         
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Heather A. Vallier, M.D. MetroHealth Medical Center
More Information

Responsible Party: Heather A. Vallier, Professor of Orthopaedic Surgery, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00644397     History of Changes
Other Study ID Numbers: IRB06-00029
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Heather A. Vallier, MetroHealth Medical Center:
distal femur fracture
locked plates
functional outcomes
cost management
femur head
femur neck

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries