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

June 27, 2011 updated by: Nova Scotia Health Authority

Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

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

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre

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 (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LISS
Treatment of distal femur fracture with less invasive stabilization system
Device: LISS
treatment of distal femur fractures with less invasive stabilization systems
Active Comparator: Standard Treatment
Treatment of distal femoral fractures using locking condylar plates or dynamic condylar screws
Device: Plates to treat fractures of the distal femur
use of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed union or nonunion of the distal femur
Time Frame: 12 months post operative
Determined via radiographic analysis
12 months post operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Collaborators

AO Research Fund
Synthes Canada

Investigators

  • Principal Investigator: Ross K Leighton, MD, FRCS(C), Capital Health, Canada

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.

General Publications

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

March 1, 2003

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

November 1, 2007

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA-RL-003

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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