DIFFIR - Geriatric Distal Femur Fixation Versus Replacement
Canada140 participantsStarted 2021-10-01
Plain-language summary
The current standard of care for most intra-articular distal femur fractures (above the knee joint) in geriatric patients is a surgical fixation using plates and screws to hold the fracture pieces in the correct position, until the fracture as healed.
However, surgical fixation of these complex fractures in geriatric patients, is associated with significant complications, such as non-union (when the broken bone does not heal properly), infection and the need for revision surgery. Additionally, surgical fixation requires prolonged immobilization of of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Geriatric patients, especially those frail and with cognition impairment, are unable to adhere to the immobilization restrictions, which leads to an increased risk of fixation failure (broken bone does not heal).
Another treatment option for those patients is an acute distal femoral replacement (artificial knee), where damaged parts of the knee joint are replaced with artificial prosthesis. This procedure allows patients to walk immediately after the surgery and faster return to previous level of function, therefore avoiding the complications for immobilization.
There is a lack of guideline and evidence to suggest which surgical technique is best to provide superior function outcomes, lower complications and reduced costs. The proposed study seeks to answer this question by performing a large clinical trial comparing knee replacement versus surgical fixation in geriatric patients with distal femur fracture.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients
* 65 years and older
* Isolated fracture of the distal femur (Classification 33)
* Fracture is amendable to both treatments
* Fracture is acute (within 2 weeks from time of injury)
* Patient was ambulatory (with or without walking aids) prior to the injury
* Independent or moderately frail with score of 3 to 6 on the Clinical Frailty Scale
* Patient is able to read and understand English, French, or Spanish
* Patient or substitute decision maker is able to provide written informed consent to participate in the study
Exclusion Criteria:
* Active or previous infection around the fracture (soft tissue or bone)
* Open fracture
* Bilateral femur fractures
* Major vascular injuries requiring intervention, compartment syndrome and major neurologic injuries
* Pathological fracture excluding osteoporosis
* Previous surgical fixation or total knee replacement of the distal femur or proximal tibia
* Previous surgical fixation or hemi/total replacement of the hip
* Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair
* Polytrauma (Injury Severity Score \> 15) or any associated major injuries of the lower extremities
* Previous medical diagnosis of dementia
* Medical or surgical contra-indication to surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oxford Knee Score (OKS)
Timeframe: Our primary outcome is knee pain and function as measured by repeated measures of the Oxford Knee Score at 3, 6, 9 and 12 -months post-surgery to detect a 5 point improvement on the OKS with 0.5 correlation between assessments.