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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00552331

Enrollment

150

Registered

2007-11-01

Start date

2003-03-31

Completion date

2009-07-31

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Fractures

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.

Interventions

DEVICEPlates to treat fractures of the distal femur

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

DEVICELISS

treatment of distal femur fractures with less invasive stabilization systems

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026