Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Information source: Capital District Health Authority, Canada
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Femoral Fractures
Intervention: Plates to treat fractures of the distal femur (Device)
Phase: Phase 4
Status: Recruiting
Sponsored by: Capital District Health Authority, Canada Official(s) and/or principal investigator(s):
Ross K Leighton, MD, FRCS(C), Principal Investigator, Affiliation: Capital Health, Canada
Overall contact:
Kelly Trask, B.Eng, MSc, CCRP, Phone: 902-473-3161, Email: kelly.trask@cdha.nshealth.ca
Summary
The purpose of this study is to determine whether the rate of fracture healing and fracture
union, repaired with the LISS device, will be as good as or better than the usual fracture
fixation systems.
Clinical Details
Official title: Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Study design: Randomized, Open Label, Active Control, Single Group Assignment
Primary outcome: Delayed union or nonunion of the distal femur
Secondary outcome: Time to clinical healingFunction as assessed by patient Frequency of adverse events Range of motion Gait analysis
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The patient has read and agree to the consent
- Patient is 16 years or older (bones have finished growing)
- The injury happened in the last 14 days
Exclusion Criteria:
- The patient taking part in another study
- The patient has an infection at the operative site
- The patient has a health condition that affects bone healing or interferes with their
ability to complete the study requirements (questionnaires, examinations), for example
Paget's disease or osteomalacia
- The patient is taking medication that affects bone healing (such as systemic
steroids)
- The patient has malignant (tumor) disease
- The patient is unable to attend follow-up clinic visits
Locations and Contacts
Kelly Trask, B.Eng, MSc, CCRP, Phone: 902-473-3161, Email: kelly.trask@cdha.nshealth.ca
QEII Health Sciences Centre, Halifax, Nova Scotia B3H 3A7, Canada; Recruiting
Ross K Leighton, MS, FRCS(C), Principal Investigator
David P Petrie, MD, CM, FRCS(C), FACS, Sub-Investigator
Michael J Dunbar, MD, FRCS(C), Sub-Investigator
Kevin Deluzio, PhD, P.Eng, Sub-Investigator
Additional Information
Starting date: March 2003
Last updated: October 30, 2007
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