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

This study has been completed.
Sponsor:
Collaborators:
Synthes Canada
AO Research Fund
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00552331
First received: October 30, 2007
Last updated: June 27, 2011
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Femoral Fractures
Device: Plates to treat fractures of the distal femur
Device: LISS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Delayed union or nonunion of the distal femur [ Time Frame: 12 months post operative ] [ Designated as safety issue: No ]
    Determined via radiographic analysis


Secondary Outcome Measures:
  • Time to clinical healing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    assessed by weight-bearing ability and pain

  • Function as assessed by patient [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Assessed using LEM, SMFA, and SF-36 questionnaires

  • Frequency of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Range of motion [ Time Frame: Post-op, 6 weeks, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Gait analysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552331

Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Capital District Health Authority, Canada
Synthes Canada
AO Research Fund
Investigators
Principal Investigator: Ross K Leighton, MD, FRCS(C) Capital Health, Canada
  More Information

No publications provided

Responsible Party: Ross Leighton, MD, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00552331     History of Changes
Other Study ID Numbers: CDHA-RL-003
Study First Received: October 30, 2007
Last Updated: June 27, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 22, 2014