Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single Implant Fixation (SIF), Dual Implant Fixation (DIF).
- Who it may be relevant to
- Registry conditions: Distal Femur Fractures. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - 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) .
Primary outcome measures
- 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]
Secondary outcome measures (12)
- Pain rating [Time frame: 2 years]
- Functional ability [Time frame: 2 years]
- Weight-bearing [Time frame: 2 years]
- Mobility [Time frame: 3, 6, 12 and 24 months.]
- Health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). [Time frame: 2 years]
- Health-resource utilization [Time frame: 2 years]
- Complications [Time frame: 2 years]
- Re-operations (Type) [Time frame: 2 years]
- Re-operations (Reason) [Time frame: 2 years]
- Radiographic [Time frame: 2 years]
- Successful initiation of sites [Time frame: Through study completion, an average of 24 months.]
- Data quality [Time frame: Through study completion, an average of 24 months.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Fraser Orthopaedic Institute — New Westminster
- London Health Sciences Centre — London
Identifiers
NCT: NCT06944964 · DFF Feasibility Study