Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 30, 2007
CompletedFirst Posted
Study publicly available on registry
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJune 28, 2011
May 1, 2009
6.3 years
October 30, 2007
June 27, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Delayed union or nonunion of the distal femur
Determined via radiographic analysis
12 months post operative
Secondary Outcomes (5)
Time to clinical healing
12 months
Function as assessed by patient
6 months, 12 months
Frequency of adverse events
12 months
Range of motion
Post-op, 6 weeks, 3 months, 6 months, 12 months
Gait analysis
12 months
Study Arms (2)
LISS
ACTIVE COMPARATORTreatment of distal femur fracture with less invasive stabilization system
Standard Treatment
ACTIVE COMPARATORTreatment of distal femoral fractures using locking condylar plates or dynamic condylar screws
Interventions
use of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nova Scotia Health Authoritylead
- Synthes Canadacollaborator
- AO Research Fundcollaborator
Study Sites (1)
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
Related Publications (1)
Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.
PMID: 36197809DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ross K Leighton, MD, FRCS(C)
Capital Health, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 30, 2007
First Posted
November 1, 2007
Study Start
March 1, 2003
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
June 28, 2011
Record last verified: 2009-05