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

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.

Study Overview

• Status: Recruiting
• Conditions: Distal Femur Fractures
• Intervention / Treatment: Procedure: Single Implant Fixation (SIF); Procedure: Dual Implant Fixation (DIF)

Detailed Description

The Investigators aim to conduct a multi-centre, preliminary RCT to determine the feasibility and inform the design of a definitive trial comparing patient-important outcomes between patients aged 40 years and older with distal femur fractures managed with SIF vs. DIF.

Primary Aim: Evaluate the feasibility of conducting a larger, definitive trial examining outcomes following SIF vs. DIF for DFFs in older or compromised adults. Our primary outcomes for this objective will be 1) recruitment and retention at the participating sites; and 2) site investigator feedback regarding barriers to protocol adherence.

Secondary Aims: Pilot the collection of candidate outcome measures to determine the optimal primary end point and sample size for a definitive trial. Our primary outcome for this objective will be the Oxford Knee Score, and secondary outcomes will include a range of patient-reported quality of life (QOL) measures, and objective clinical measures.

In addition, the study includes an ultrasound sub-study aimed at evaluating the feasibility of using ultrasound imaging to monitor bone healing and detect complications like non-union in patients with DFF.

Participants will be randomly assigned to receive either SIF or DIF, with SIF generally involving a single implant (such as a lateral locked plate or retrograde intramedullary nail) and DIF using a combination of implants (e.g., dual plates or a nail and plate). This randomized design will enable us to assess whether dual implant fixation offers improved clinical outcomes, such as reduced morbidity and faster weight-bearing recovery, compared to the more traditional single implant fixation.

Non-Randomized Participation: The investigators will collect data surrounding the number of eligible patients approached for consent, eligible patients not approached for consent and reason why, along with the proportion of patients who do not consent and reasons why to refine our strategy for the definitive trial. For patients who are excluded due to a lack of clinical equipoise, the investigators will provide the option of participating in a concurrent cohort study.This study will record the same variables as the RCT.

The trial will take place at four major trauma centers across Canada: London Health Sciences Centre - Victoria Hospital, St. Michael's Hospital, Sunnybrook Health Sciences Centre, and Alberta Health Services Centre. Participants will receive follow-up visits at these centers, which will include clinical check-ups, rehabilitation sessions, and imaging assessments to track their recovery progress.

The data gathered from this feasibility study will provide critical insights into the practicality of a larger-scale trial and will help inform future treatment strategies for distal femur fractures.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emil Schemitsch, MD, FRCS(C); Phone Number: 33307 519-685-8500; Email: Emil.Schemitsch@lhsc.on.ca
• Study Contact Backup: Name: Abdel-Rahman Lawendy, MD, FRCS(C); Phone Number: 58086 519-685-8500; Email: AbdelRahman.Lawendy@lhsc.on.ca

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada
      • Not yet recruiting
      • Fraser Orthopaedic Institute
      • Contact: David Cinats, MD, FRCS(C); Phone Number: 604-545-1405
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • London Health Sciences Centre
      • Principal Investigator: Emil Schemitsch, MD, FRCS(C)
      • Contact: Lawson Health Research Institute; Phone Number: 519-685-8500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: 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.
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.	Procedure: 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) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain rating	Via the numeric pain rating scale (NRS). 0-10; higher scores = worse pain.	2 years
Functional ability	Via the PROMIS-Physical Function Short. Higher = better for function domains Higher = worse for symptom domains (e.g., pain, fatigue). Form.	2 years
Weight-bearing	Using the Function IndeX for Trauma (FIX-IT) score.0-100; higher scores = better function.	2 years
Mobility	Via the Extended Timed Up and Go (TUG) test starting at 3-months.	3, 6, 12 and 24 months.
Health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).	via Euro-Qol 5 Dimension (EQ5D). Higher scores = better health-related quality of life.	2 years
Health-resource utilization	Using the patient-reported Ambulatory and Home Care Record.	2 years
Complications	Including non-union, malunion, infection, implant failure and arthritis.	2 years
Re-operations (Type)	Reviewing the type of secondary procedure	2 years
Re-operations (Reason)	Reviewing the reason for the secondary procedure	2 years
Radiographic	To assess fracture healing and union. Anteroposterior and lateral x-rays of all patients will be obtained at the standard follow-up intervals. The independent adjudication committee will assess fracture healing and union.	2 years
Successful initiation of sites	Site fully approved, trained, and ready to begin recruiting participants.	Through study completion, an average of 24 months.
Data quality	Proportion of CRFs with no missing data/outstanding queries	Through study completion, an average of 24 months.
Randomization errors/cross-overs	Success: <5%, at least 90% adherence to allocated surgical technique	Through study completion, an average of 24 months.
The proportion of patients instructed to WBAT in each group	Success: a minimum of 80% of patients are instructed to WBAT postoperative in each group	Through study completion, an average of 24 months.
Barriers to protocol adherence	qualitative	Through study completion, an average of 24 months.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Single Implant Fixation; Dual Implant Fixation; Dual Plate Fixation; Combination nail-plate fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Femoral Fractures, Distal
• Other Study ID Numbers: DFF Feasibility Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No