A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures

Study Overview
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Brief Summary
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This study looks at two (2) types of surgical treatments and hopes to answer the question, which is the best way to surgically treat a distal femur fracture? Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

Detailed Description
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The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

Official Title
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Study of Locked Plates Versus Intramedullary Nails in Distal Femur Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (S.O.L.V.E.D)

Conditions
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Femoral Fractures

Intervention / Treatment
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* Device: reamed, interlocking intramedullary nail
* Device: locking periarticular plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally mature Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA Fracture requiring operative treatment amenable to either IM nail or plate Informed consent obtained Patient is English speaking Exclusion Criteria: Fracture of the metaphyseal distal femur with intra-articular communition, Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair, Pathological fracture, Known metabolic bone disease, Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating Symptomatic knee arthritis Soft tissue injuries compromising either treatment method with nail or plate Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures Immunocompromised Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired) Current or impending incarceration Unlikely to follow-up in surgeon's estimation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IM Nails<br>Reamed, Interlocking Intramedullary Nail - Randomized treatment | Device: reamed, interlocking intramedullary nail<br>* Standard of care device for femur fracture repair<br>|
| Other: Plate Fixation<br>Locking Periarticular Plate - Randomized Treatment | Device: locking periarticular plate<br>* Standard of care device for femur fractures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D | EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best. | 3 months, 6 months, 12 months | 
| Short Musculoskeletal Functional Assessment (SMFA) Score | The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function. | 3 months, 6 months, 12 months | 
| EQ Index | EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best. | 3 months, 6 months, 12 months | 
| SMFA - Bother Index | The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury. | 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valgus of Over 5 Degrees | Valgus is a deformity involving oblique displacement of part of a limb away from the midline. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal femur, femur fracture