Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT01973712

Conditions

Periprosthetic Fractures

Distal Femur Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Locked Compression Plating

Retrograde Intramedullary Nailing (RIMN)

Study Details

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.

Conditions

Periprosthetic Fractures

Distal Femur Fractures

Study ID

NCT01973712

Start date

May, 2014

Status verified date

Jun, 2021

Completion date

Jan, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

Interventions

Locked Compression Plating

Retrograde Intramedullary Nailing (RIMN)

Primary outcome measure

  • Timed Up and Go (TUG) test [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Milena Vicente, RN, CCRP

416-864-6060vicentem@smh.ca

Locations

St. Michael's Hospital, Department of Orthopaedic Surgery

Recruiting

Toronto, Ontario, Canada, M5C 1R6

Contacts

Milena Vicente, RN, CCRP

416-864-6060vicentem@smh.ca

Principal Investigator:

Aaron Nauth, MD, FRCSC

More Information

Sponsor

Unity Health Toronto

Last update posted

Jun 18, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2021-06-18.