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

NCT ID: NCT00552331

Last Updated: 2011-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Femoral Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LISS

Treatment of distal femur fracture with less invasive stabilization system

Group Type ACTIVE_COMPARATOR

LISS

Intervention Type DEVICE

treatment of distal femur fractures with less invasive stabilization systems

Standard Treatment

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

Group Type ACTIVE_COMPARATOR

Plates to treat fractures of the distal femur

Intervention Type DEVICE

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

Interventions

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Plates to treat fractures of the distal femur

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

Intervention Type DEVICE

LISS

treatment of distal femur fractures with less invasive stabilization systems

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synthes Canada

INDUSTRY

Sponsor Role collaborator

AO Research Fund

OTHER

Sponsor Role collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Capital District Health Authority, Canada

Principal Investigators

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Ross K Leighton, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Capital Health, Canada

Locations

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QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.

Reference Type DERIVED
PMID: 36197809 (View on PubMed)

Other Identifiers

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CDHA-RL-003

Identifier Type: -

Identifier Source: org_study_id

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