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

Femoral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552331
• Other study ID #: CDHA-RL-003
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2007
• Last updated: June 27, 2011
• Start date: March 2003
• Est. completion date: July 2009

Study information

• Verified date: May 2009
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone

Intervention

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
• LISS
treatment of distal femur fractures with less invasive stabilization systems

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (3)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	AO Research Fund, Synthes Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed union or nonunion of the distal femur	Determined via radiographic analysis	12 months post operative	No
Secondary	Time to clinical healing	assessed by weight-bearing ability and pain	12 months	No
Secondary	Function as assessed by patient	Assessed using LEM, SMFA, and SF-36 questionnaires	6 months, 12 months	No
Secondary	Frequency of adverse events		12 months	Yes
Secondary	Range of motion		Post-op, 6 weeks, 3 months, 6 months, 12 months	No
Secondary	Gait analysis		12 months	No