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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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.
| 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.
| 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 |
| 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. |
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Inclusion Criteria:
Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and
Rorabeck type 1, 2) and either:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emil Schemitsch, MD, FRCS(C) | Contact | 519-685-8500 | 33307 | Emil.Schemitsch@lhsc.on.ca |
| Abdel-Rahman Lawendy, MD, FRCS(C) | Contact | 519-685-8500 | 58086 | AbdelRahman.Lawendy@lhsc.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraser Orthopaedic Institute | Not yet recruiting | New Westminster | British Columbia | Canada |
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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)).
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| 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) . |
|
| 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. |
| London Health Sciences Centre | Recruiting | London | Ontario | N6A 5A5 | Canada |
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| ID | Term |
|---|---|
| D000092524 | Femoral Fractures, Distal |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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