Clinical trial NCT06944964: Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
Official title: Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Distal Femur Fractures
Keywords: Single Implant Fixation
Dual Implant Fixation
Dual Plate Fixation
Combination nail-plate fixation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2025-04-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility Outcomes - Recruitment
timeFrame: Through study completion, an average of 1 year.
measure: Feasibility Outcomes - Retention
timeFrame: Through study completion, an average of 1 year.
measure: Functional Ability
timeFrame: 2 year
Secondary outcomes:
measure: Pain rating
timeFrame: 2 years
measure: Functional ability
timeFrame: 2 years
measure: Weight-bearing
timeFrame: 2 years
measure: Mobility
timeFrame: 3, 6, 12 and 24 months.
measure: Health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
timeFrame: 2 years
measure: Health-resource utilization
timeFrame: 2 years
measure: Complications
timeFrame: 2 years
measure: Re-operations (Type)
timeFrame: 2 years
measure: Re-operations (Reason)
timeFrame: 2 years
measure: Radiographic
timeFrame: 2 years
measure: Successful initiation of sites
timeFrame: Through study completion, an average of 24 months.
measure: Data quality
timeFrame: Through study completion, an average of 24 months.
measure: Randomization errors/cross-overs
timeFrame: Through study completion, an average of 24 months.
measure: The proportion of patients instructed to WBAT in each group
timeFrame: Through study completion, an average of 24 months.
measure: Barriers to protocol adherence
timeFrame: Through study completion, an average of 24 months.
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Fraser Orthopaedic Institute
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: