Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures

Phase 4

Completed

• Conditions: Femoral Fractures
• Interventions: Device: LISS; Device: Plates to treat fractures of the distal femur

• Registration Number: NCT00552331
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-10-30
• Study First Posted: 2007-11-01
• Status Verified: 2009-05
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LISS	LISS	Treatment of distal femur fracture with less invasive stabilization system
Standard Treatment	Plates to treat fractures of the distal femur	Treatment of distal femoral fractures using locking condylar plates or dynamic condylar screws

Primary Outcome Measures

Name	Time	Method
Delayed union or nonunion of the distal femur	12 months post operative	Determined via radiographic analysis

Secondary Outcome Measures

Name	Time	Method
Time to clinical healing	12 months	assessed by weight-bearing ability and pain
Function as assessed by patient	6 months, 12 months	Assessed using LEM, SMFA, and SF-36 questionnaires
Frequency of adverse events	12 months
Range of motion	Post-op, 6 weeks, 3 months, 6 months, 12 months
Gait analysis	12 months

Trial Locations

Locations (1)

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada