A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures

Study Overview
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Brief Summary
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This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia 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 multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia 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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Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)

Conditions
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Tibial 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, Extra-articular fracture of the proximal tibia extending into the metaphyseal with or without intra-articular extension not requiring open reduction with complete anteroposterior (AP) and lateral radiographs, Major fracture line not closer than 4cm from the proximal tibial articular surface Fracture requiring operative treatment amenable to either IM nail or plate Surgeon agreed to randomize patient Informed consent obtained Patient is English speaking Exclusion Criteria: Tibial shaft fractures not amenable to intramedullary nailing (i.e.fracture is less than 4 cm from joint surface), Fracture of the proximal tibia with intraarticular extension requiring open reduction, Known metabolic bone disease Separate displaced tibial tubercle fragment, Soft tissue injuries compromising treatment method with nail,plate or both. Fractures with vascular injury (Gustillo Type IIIC injury) requiring repair, Compartment syndrome of the leg diagnosed preoperatively, Pathological fractures, Retained hardware or existing deformity in the affected limb that would complicate IM nailing,plating or both, Symptomatic knee arthritis. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

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: Randomized Treatment - Nail<br>Randomized Treatment - Nail | Device: reamed, interlocking intramedullary nail<br>* Standard of care device for tibia fracture repair; Randomized Treatment - Nail<br>|
| Other: Randomized Treatment - Plate<br>Randomized Treatment - Plate | Device: locking periarticular plate<br>* Standard of care device for tibia fracture repair; Randomized Treatment - Plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' Quality of Life at 3 Months | The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems. | 3 months | 
| Participants' Quality of Life at 6 Months | The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems. | 6 months | 
| Participants' Quality of Life at 12 Months | The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The higher the score the less quality of life problems. | 12 months | 
| Injury Related Limitations and Concerns at 3 Months | Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother. | 3 months | 
| Injury Related Limitations and Concerns at 6 Months | Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother. | 6 months | 
| Injury Related Limitations and Concerns at 12 Months | Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less difficulty and bother. | 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Fracture Nonunions | A nonunion is when a broken bone fails to heal. This is determined by a review of the participants' medical records and x-rays. | 12 months | 
| Number of Participants With Superficial Infections | A superficial infection is an infection that occurs at the wound only. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed. | 6 months | 
| Number of Participants With Deep Infections | A deep infection is an infection occurring at the site of the nail or plate. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed. | 6 months | 
| Number of Participants With Compartment Syndrome | Compartment syndrome is a painful condition that occurs when pressure within the muscles builds to dangerous levels. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed. | 6 months | 
| Number of Participants With Malunion (>5 Degrees Varus/Valgus) | Malunion is when a broken bone heals in an abnormal position. In this case, more than a 5 degree angle varus (curving into) or valgus (curving away). This is determined by a review of the participants' medical records and x-rays. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tibia fracture, proximal tibia, interlocking intramedullary nail, locking periarticular plate, open reduction, internal fixation