pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

Distal Femur Fracture Clinical Trial

— pDIFFIR  

Official title:

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femur Replacement (DFR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805774
• Other study ID #: 23-001
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 10, 2032

Study information

• Verified date: January 2024
• Source: Unity Health Toronto
• Contact: Cassandra Tardif-Theriault
• Phone: 416-864-6060
• Email: cassandra.tardif-theriault[@]unityhealth.to
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Periprosthetic distal femur fractures are a significant source of morbidity and mortality for elderly patients. One treatment option involved a surgical fixation with plates or nails, screws and cables/wires along the side of your fractured bone. The second method consists in replacing your knee joint with an artificial knee prosthesis (artificial knee joint). The primary objective is to determine if acute distal femur replacement improves knee pain and functional outcomes compared to surgical fixation. Secondary outcomes are mortality, reoperation, complications, post-operative pain and quality of life. A health economic analysis will be conducted to assess the cost-effectiveness of both treatments. A total of 148 patients (74/group) will be enrolled in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 10, 2032
• Est. primary completion date: December 10, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• • 65 years and older
• Isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (Lewis and Rorabeck Type 1-2)
• Fracture is acute (within 1 week from time of injury)
• Patient was ambulatory (with or without walking aids) in the community and at home prior to the injury
• Independent or moderately frail with score of 3 to 6 on the validated Clinical Frailty Scale
• Patient is able to read and understand the consent form document, or an interpreter is available to the patient at the time of consent and follow-up
• Patient or substitute decision maker is able to provide written informed consent to participate in the study

Exclusion Criteria:

• • Active infection around the fracture (soft tissue or bone)
• Open fracture
• Bilateral femur fractures
• Major neuro-vascular injury requiring intervention, compartment syndrome and major neurologic injuries
• Pathological fracture excluding osteoporosis
• Ipsilateral total knee arthroplasty using revision components (varus/valgus constraint, stemmed femoral components)
• Periprosthetic distal femur fracture around a loose or failing primary total knee arthroplasty (Lewis and Rorabeck Type III)
• Ipsilateral primary partial knee or patellofemoral arthroplasty
• Previous ORIF of the distal femur or proximal tibia or patella
• Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair
• Poly-trauma status (Injury Severity Score>15) or any associated major injuries of the lower extremities that may hinder post-operative ambulation
• Medical contraindication to surgery

Related Conditions & MeSH terms

• Distal Femur Fracture
• Femoral Fractures
• Fractures, Bone
• Knee Fracture
• Periprosthetic Fractures

Intervention

Procedure:
• Distal Femur Replacement
Knee surgery to remove the lower part of the femur and knee joint (where the broken bones are) and will replace them with an artificial knee joint (prosthesis).
• Surgical fixation
Knee surgery to fix the fracture, that can use wires, nails, screws, pins or plates to health and fix the bones together.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee function	Compare knee pain between the two groups using the Oxford Knee Score - which is a patient reported outcome measure. It assess knee function and gives a rating from 0 to 48 - being 0 bad knee function and 48 - excellent knee function.	12 months
Secondary	Mortality	Track patient's death.	24 months