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Completed

NCT Number: NCT00552331

Evaluation of 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.

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Key information

Conditions

Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plates to treat fractures of the distal femur

Device

use of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures

LISS

Device

treatment of distal femur fractures with less invasive stabilization systems

Primary outcomes

  1. Delayed union or nonunion of the distal femur

    Time frame: 12 months post operative

    Determined via radiographic analysis

Secondary outcomes

  1. Time to clinical healing

    Time frame: 12 months

    assessed by weight-bearing ability and pain

  2. Function as assessed by patient

    Time frame: 6 months, 12 months

    Assessed using LEM, SMFA, and SF-36 questionnaires

  3. Frequency of adverse events

    Time frame: 12 months

  4. Range of motion

    Time frame: Post-op, 6 weeks, 3 months, 6 months, 12 months

  5. Gait analysis

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • AO Research Fund
  • Synthes Canada

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Nov 1, 2007
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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