Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults

NCT06944964 | Recruiting

• 1 other identifier: DFF Feasibility Study
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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:
• Be randomly assigned to receive either SIF or DIF for their DFF treatment
• 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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Feasibility Outcomes - Recruitment

  Recruitment - 1) Recruitment (number of patients enrolled per-month). Success will be considered as each site enrolling a minimum mean of 0.6 patients per-month. This is a conservative estimate based on our previous trials in similar populations, and we expect that each site will screen a minimum of twice this number. * Number of patients enrolled per month * Success if each site able to enroll mean of 0.6 patients per month

  Through study completion, an average of 1 year.

• Feasibility Outcomes - Retention

  Retention - (proportion of patients that complete one-year follow-up). Success will be considered a minimum of 85% of patients with complete one-year data. * Proportion of patients that complete 1 year follow up * Success: 85%

  Through study completion, an average of 1 year.

• Functional Ability

  Via the validated Oxford Knee Score. It ranges from 0 to 48, with higher scores indicating better outcomes (i.e., less pain and better function).

  2 year

Secondary Outcomes (15)

• Pain rating

  2 years

• Functional ability

  2 years

• Weight-bearing

  2 years

• Mobility

  3, 6, 12 and 24 months.

• Health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).

  2 years

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Procedure: Single Implant Fixation (SIF)

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

ACTIVE COMPARATOR

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

Procedure: Dual Implant Fixation (DIF)

Interventions

Single Implant Fixation (SIF) PROCEDURE

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.

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

Dual Implant Fixation (DIF) PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and
• Rorabeck type 1, 2) and either:
• Age ≥ 60 years or;
• Age 18-60 years with one or more of:
• i. Osteoporosis ii. Obesity (Body Mass Index \>30) iii. Metaphyseal comminution iv. Diabetes
• Fracture amenable to plating and nailing
• Ability to read and speak English or availability of a translator
• Acute fractures (within 14-days of injury)
• No surgeon preference regarding SIF vs. DIF
• Provision of informed consent

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (2)

Fraser Orthopaedic Institute

New Westminster, British Columbia, Canada

NOT YET RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Emil Schemitsch, MD, FRCS(C)

CONTACT

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

Abdel-Rahman Lawendy, MD, FRCS(C)

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multi-centered, preliminary feasibility RCT across 4 level I trauma centers comparing SIF to DIF for DFFs. Participants are randomized into one of two groups, and each group receives a different intervention (Single Implant Fixation (SIF) or Dual Implant Fixation (DIF)).

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: April 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2030
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)