DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

Launched by UNITY HEALTH TORONTO · Aug 30, 2019

Keywords

ClinConnect Summary

The DIFFIR trial is studying two different surgical treatments for older adults who have a specific type of broken bone called a distal femur fracture, which occurs just above the knee. Currently, many patients undergo a procedure where plates and screws are used to hold the broken pieces together. However, this method can lead to complications, such as the bone not healing properly and the need for further surgery, especially for older patients who may have difficulty keeping the leg still during recovery. An alternative treatment is to replace the damaged parts of the knee joint with an artificial joint, which allows patients to walk shortly after surgery and can help them get back to their normal activities faster.

To participate in this trial, individuals need to be 65 years or older and have a recent isolated fracture of the distal femur that can be treated with either method. They should have been able to walk before the injury, and their overall health should allow them to undergo surgery. Participants will be closely monitored to see which treatment leads to better healing and fewer complications. This study aims to provide important information about which surgical option is best for older adults with this type of fracture, helping doctors make better decisions in the future.

Gender

ALL

Eligibility criteria

• 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