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Periprosthetic Distal Femur Fracture

Primary Purpose

Periprosthetic Fractures, Distal Femur Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Locked Compression Plating
Retrograde Intramedullary Nailing (RIMN)
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periprosthetic Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

Age 18 years and older Displaced periprosthetic fracture of the distal femur Fracture amenable to both treatment groups, in the opinion of the investigator Knee prosthesis is well-fixed and non-stemmed Open box femoral component Provision of written informed consent

EXCLUSION CRITERIA:

Presence of an active infection around the fracture (soft tissue or bone) Open fracture Injury Severity Score (ISS) > 15 or any associated major injuries of the lower extremities Medical contraindication to surgery Pregnant women Likely problems, in the judgment of the investigators, with maintaining follow-up

Sites / Locations

  • St. Michael's Hospital, Department of Orthopaedic SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Locked Compression Plating

Retrograde Intramedullary Nailing (RIMN)

Arm Description

A direct lateral approach to the distal femur will be employed utilizing minimally invasive and indirect reduction techniques. After fracture reduction is achieved with the use of intra-operative fluoroscopy, a locking plate will be provisionally implanted. Following confirmation of placement, definitive fixation will follow with multiple locking screws in the distal fragment and bicortical screw fixation proximally. A standard layered closure will follow

The previous midline knee incision will be employed to access to the knee joint, allowing exposure of the femoral start point via the open box in the femoral component. Following reaming of the canal, an appropriately sized retrograde nail will be inserted. Intra-operative fluoroscopy will be used to confirm reduction. Both proximal and distal locking screws will be used to transfix the nail. A standard layered closure will follow.

Outcomes

Primary Outcome Measures

Timed Up and Go (TUG) test
The TUG is a very simple timed test that was introduced in 1991 to measure mobility in the elderly. It involves documenting the time, in seconds, taken for subjects to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, and sit down again

Secondary Outcome Measures

Rates of re-operation

Full Information

First Posted
October 25, 2013
Last Updated
June 16, 2021
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01973712
Brief Title
Periprosthetic Distal Femur Fracture
Official Title
Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. Despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture. Our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. One treatment consists of open surgery and the placement of a plate and screws along the side of the femur. The other consists of implanting an intramedullary nail in the femur. The goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periprosthetic Fractures, Distal Femur Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Locked Compression Plating
Arm Type
Experimental
Arm Description
A direct lateral approach to the distal femur will be employed utilizing minimally invasive and indirect reduction techniques. After fracture reduction is achieved with the use of intra-operative fluoroscopy, a locking plate will be provisionally implanted. Following confirmation of placement, definitive fixation will follow with multiple locking screws in the distal fragment and bicortical screw fixation proximally. A standard layered closure will follow
Arm Title
Retrograde Intramedullary Nailing (RIMN)
Arm Type
Experimental
Arm Description
The previous midline knee incision will be employed to access to the knee joint, allowing exposure of the femoral start point via the open box in the femoral component. Following reaming of the canal, an appropriately sized retrograde nail will be inserted. Intra-operative fluoroscopy will be used to confirm reduction. Both proximal and distal locking screws will be used to transfix the nail. A standard layered closure will follow.
Intervention Type
Procedure
Intervention Name(s)
Locked Compression Plating
Intervention Type
Procedure
Intervention Name(s)
Retrograde Intramedullary Nailing (RIMN)
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG) test
Description
The TUG is a very simple timed test that was introduced in 1991 to measure mobility in the elderly. It involves documenting the time, in seconds, taken for subjects to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, and sit down again
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Rates of re-operation
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Rates of malunion
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Age 18 years and older Displaced periprosthetic fracture of the distal femur Fracture amenable to both treatment groups, in the opinion of the investigator Knee prosthesis is well-fixed and non-stemmed Open box femoral component Provision of written informed consent EXCLUSION CRITERIA: Presence of an active infection around the fracture (soft tissue or bone) Open fracture Injury Severity Score (ISS) > 15 or any associated major injuries of the lower extremities Medical contraindication to surgery Pregnant women Likely problems, in the judgment of the investigators, with maintaining follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Milena Vicente, RN, CCRP
Phone
416-864-6060
Ext
2608
Email
vicentem@smh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Nauth, MD, FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emil Schemitsch, MD, FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital, Department of Orthopaedic Surgery
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena Vicente, RN, CCRP
Phone
416-864-6060
Ext
2608
Email
vicentem@smh.ca
First Name & Middle Initial & Last Name & Degree
Emil Schemitsch, MD, FRCAC
First Name & Middle Initial & Last Name & Degree
Aaron Nauth, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Michael McKee, MD, FRCSC

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
derived

Learn more about this trial

Periprosthetic Distal Femur Fracture

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