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

Primary Purpose

Femoral Fractures

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Plates to treat fractures of the distal femur
LISS
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Fractures

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • QEII Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LISS

Standard Treatment

Arm Description

Treatment of distal femur fracture with less invasive stabilization system

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

Outcomes

Primary Outcome Measures

Delayed union or nonunion of the distal femur
Determined via radiographic analysis

Secondary Outcome Measures

Time to clinical healing
assessed by weight-bearing ability and pain
Function as assessed by patient
Assessed using LEM, SMFA, and SF-36 questionnaires
Frequency of adverse events
Range of motion
Gait analysis

Full Information

First Posted
October 30, 2007
Last Updated
June 27, 2011
Sponsor
Nova Scotia Health Authority
Collaborators
Synthes Canada, AO Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00552331
Brief Title
Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Official Title
Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Synthes Canada, AO Research Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LISS
Arm Type
Active Comparator
Arm Description
Treatment of distal femur fracture with less invasive stabilization system
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
Treatment of distal femoral fractures using locking condylar plates or dynamic condylar screws
Intervention Type
Device
Intervention Name(s)
Plates to treat fractures of the distal femur
Intervention Description
use of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures
Intervention Type
Device
Intervention Name(s)
LISS
Intervention Description
treatment of distal femur fractures with less invasive stabilization systems
Primary Outcome Measure Information:
Title
Delayed union or nonunion of the distal femur
Description
Determined via radiographic analysis
Time Frame
12 months post operative
Secondary Outcome Measure Information:
Title
Time to clinical healing
Description
assessed by weight-bearing ability and pain
Time Frame
12 months
Title
Function as assessed by patient
Description
Assessed using LEM, SMFA, and SF-36 questionnaires
Time Frame
6 months, 12 months
Title
Frequency of adverse events
Time Frame
12 months
Title
Range of motion
Time Frame
Post-op, 6 weeks, 3 months, 6 months, 12 months
Title
Gait analysis
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross K Leighton, MD, FRCS(C)
Organizational Affiliation
Capital Health, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36197809
Citation
Claireaux HA, Searle HK, 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.
Results Reference
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Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures

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