pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation... | NCT05805774

Studies
pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

NCT05805774

Sponsor

Unity Health Toronto

Status

Recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

148Estimated

Phase

Not Applicable

Conditions

Distal Femur Fracture
Periprosthetic Fracture Around Prosthetic Joint Implant Knee
Knee Fracture

Interventions

Distal Femur Replacement
Surgical fixation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2025Actual

Primary Completion Date

Dec 10, 2030Estimated

Completion Date

Dec 10, 2032Estimated

First Submitted Date

Mar 28, 2023

First Submission Date that Met QC Criteria

Mar 28, 2023

First Posted Date

Apr 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2025

Last Update Posted Date

Dec 18, 2025Actual

Name	Class
Mount Sinai Hospital, Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A - DFR	Active Comparator		Procedure: Distal Femur Replacement
Group B - ORIF	Active Comparator		Procedure: Surgical fixation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Distal Femur Replacement	Procedure	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Mortality	Track patient's death.	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cassandra Tardif-Theriault	Contact	416-864-6060	77117	cassandra.tardif-theriault@unityhealth.to

Overall Officials

Name	Affiliation	Role
Amir Khoshbin, MD	Unity Health Toronto - St Michael's Hospital	Principal Investigator
Jesse Wolfstadt, MD	Mount Sinai Health Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Michael's Hospital	Recruiting	Toronto	Ontario	M5B 1W8	Canada

ID	Term
D000092524	Femoral Fractures, Distal
D000092443	Knee Fractures

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

ID	Term
D013523	Surgical Equipment
D004864	Equipment and Supplies