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Trial record 1 of 1 for:    Treatment of Periprosthetic Distal Femur Fractures
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Periprosthetic Distal Femur Fracture

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ClinicalTrials.gov Identifier: NCT01973712
Recruitment Status : Recruiting
First Posted : October 31, 2013
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE October 25, 2013
First Posted Date  ICMJE October 31, 2013
Last Update Posted Date April 24, 2020
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2014)
Timed Up and Go (TUG) test [ Time Frame: 3 months ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
Radiographic malunion, defined as greater than five degrees deviation from the anatomic axis in any plane [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2014)
Rates of re-operation [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
Rates of nonunion and implant failure [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2014)
Rates of malunion [ Time Frame: 12 months ]
Original Other Pre-specified Outcome Measures
 (submitted: October 25, 2013)
  • Rates of re-operation [ Time Frame: 12 months ]
  • Rates of infection [ Time Frame: 12 months ]
  • Patient outcomes [ Time Frame: 12 months ]
    Generic health status measurement instrument (SF-12v2) , health outcome measure (EQ-5D) and knee pain and function questionnaire (KOOS)
 
Descriptive Information
Brief Title  ICMJE Periprosthetic Distal Femur Fracture
Official Title  ICMJE Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Periprosthetic Fractures
  • Distal Femur Fractures
Intervention  ICMJE
  • Procedure: Locked Compression Plating
  • Procedure: Retrograde Intramedullary Nailing (RIMN)
Study Arms  ICMJE
  • Experimental: Locked Compression Plating
    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
    Intervention: Procedure: Locked Compression Plating
  • Experimental: Retrograde Intramedullary Nailing (RIMN)
    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: Procedure: Retrograde Intramedullary Nailing (RIMN)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2014)
94
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2013)
88
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Milena Vicente, RN, CCRP 416-864-6060 ext 2608 vicentem@smh.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01973712
Other Study ID Numbers  ICMJE PPDF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aaron Nauth, MD, FRCSC St. Michael's Hospital, Toronto
Principal Investigator: Emil Schemitsch, MD, FRCSC St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP