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

Nova Scotia Health Authority (NSHA)

Status and phase: Completed; Phase 4

Conditions: Femoral Fractures

Treatments: Device: LISS; Device: Plates to treat fractures of the distal femur

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00552331

CDHA-RL-003

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

LISS

Active Comparator group

Description:

Treatment of distal femur fracture with less invasive stabilization system

Treatment:

Device: LISS

Standard Treatment

Active Comparator group

Description:

Treatment of distal femoral fractures using locking condylar plates or dynamic condylar screws

Treatment:

Device: Plates to treat fractures of the distal femur