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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 : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.


Condition or disease Intervention/treatment Phase
Periprosthetic Fractures Distal Femur Fractures Procedure: Locked Compression Plating Procedure: Retrograde Intramedullary Nailing (RIMN) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing
Study Start Date : May 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.
Procedure: Retrograde Intramedullary Nailing (RIMN)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Rates of re-operation [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Rates of malunion [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973712


Contacts
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Contact: Milena Vicente, RN, CCRP 416-864-6060 ext 2608 vicentem@smh.ca

Locations
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Canada, Ontario
St. Michael's Hospital, Department of Orthopaedic Surgery Recruiting
Toronto, Ontario, Canada, M5C 1R6
Contact: Milena Vicente, RN, CCRP    416-864-6060 ext 2608    vicentem@smh.ca   
Sub-Investigator: Emil Schemitsch, MD, FRCAC         
Principal Investigator: Aaron Nauth, MD, FRCSC         
Sub-Investigator: Michael McKee, MD, FRCSC         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Aaron Nauth, MD, FRCSC St. Michael's Hospital, Toronto
Principal Investigator: Emil Schemitsch, MD, FRCSC St. Michael's Hospital, Toronto

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01973712     History of Changes
Other Study ID Numbers: PPDF
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Periprosthetic Fractures
Wounds and Injuries
Leg Injuries