Recruiting

SIF vs. DIF

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT06944964

Conditions

Distal Femur Fractures

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Single Implant Fixation (SIF)

Dual Implant Fixation (DIF)

Study Details

Brief summary:

The goal of this clinical trial is to assess the feasibility of conducting a larger study comparing single implant fixation (SIF) and dual implant fixation (DIF) for treating distal femur fractures (DFF) in older or compromised adults. It will also evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:

  • Can DIF improve patient outcomes compared to SIF in older or compromised adults?
  • How feasible is it to recruit and retain participants for this trial?

Participants will:

1. Be randomly assigned to receive either SIF or DIF for their DFF treatment
2. Visit the clinic for follow-ups and assessments of their recovery and bone healing, including potential ultrasound imaging for detecting complications like non-union.

Conditions

Distal Femur Fractures

Study ID

NCT06944964

Start date

Sep 1, 2025

Status verified date

Sep, 2025

Completion date

May 1, 2030

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and

Rorabeck type 1, 2) and either:
1. Age ≥ 60 years or;
2. Age 18-60 years with one or more of:

i. Osteoporosis ii. Obesity (Body Mass Index >30) iii. Metaphyseal comminution iv. Diabetes
2. Fracture amenable to plating and nailing
3. Ability to read and speak English or availability of a translator
4. Acute fractures (within 14-days of injury)
5. No surgeon preference regarding SIF vs. DIF
6. Provision of informed consent

Exclusion Criteria:

1. Candidate for primary or revision arthroplasty (surgeon opinion)
2. Periprosthetic fracture with loose implant
3. Gustillo grade III open fractures
4. Ipsilateral hip implant
5. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)
6. Non-ambulatory patients
7. Multi-trauma patient (Injury Severity Score ≥ 16)
8. Lack of bone substance or poor bone-quality which, in the surgeon's judgment, makes fixation impossible
9. Any concomitant lower-extremity injury
10. Inability to obtain informed consent due to language barrier

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A (Control): Single Implant Fixation (SIF)

Patients in this arm will undergo fixation of distal femur fractures using a single implant, which could be a lateral locked plate or a retrograde intramedullary nail.

active comparator: Group B (Experimental): Dual Implant Fixation (DIF)

Patients in this arm will undergo fixation using dual implants, either dual plate fixation or a combination of nail and plate fixation.

Interventions

Single Implant Fixation (SIF)

This intervention involves using one implant for fracture fixation. The implant can be either a lateral locked plate or a retrograde intramedullary nail, based on the surgeon's preference.

Dual Implant Fixation (DIF)

This intervention involves using two implants for fracture fixation. The combination can be either dual plate fixation (DPF) or combination nail plate fixation (NPF) .

Primary outcome measure

  • Feasibility Outcomes - Recruitment [ Time Frame: Through study completion, an average of 1 year. ]
  • Feasibility Outcomes - Retention [ Time Frame: Through study completion, an average of 1 year. ]
  • Functional Ability [ Time Frame: 2 year ]

Central Contacts and Locations

Central contacts

Emil Schemitsch, MD, FRCS(C)

519-685-8500Emil.Schemitsch@lhsc.on.ca

Abdel-Rahman Lawendy, MD, FRCS(C)

519-685-8500AbdelRahman.Lawendy@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Lawson Health Research Institute

519-685-8500

Principal Investigator:

Emil Schemitsch, MD, FRCS(C)

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Keywords

  • Single Implant Fixation
  • Dual Implant Fixation
  • Dual Plate Fixation
  • Combination nail-plate fixation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-09-15.