T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

Study Overview
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Brief Summary
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This study will utilize T1-Rho MRI to evaluate the effect of intramedullary nailing on patellofemoral articular cartilage when the surgery is performed using the infrapatellar vs. the suprapatellar approach. Subjects will be randomized to one or the other standard care surgical approaches.

Official Title
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Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?

Conditions
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Acute Tibial Fracture Requiring Intramedullary Nailing

Intervention / Treatment
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* Procedure: Intramedullary nailing of the tibia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated tibial shaft fractures indicated for intramedullary nailing, Acute tibia fractures, Closed or open tibia fractures, Skeletally mature patient between the ages of 21 and 50, No prior history of knee surgery, No prior history of knee pain, No history of degenerative joint disease or inflammatory arthropathy Not pregnant or known to be under the jurisdiction of the Department of Corrections Able to provide informed consent. Qualifies for standard care tibial IM nailing using either a suprapatellar or infrapatellar approach with no physician preference or definitive clinical indication for one or the other approach Ability to communicate, read, and write in English Intent of subject to receive follow up fracture care at the PI's institution. Exclusion Criteria: Tibial fractures requiring articular reconstruction (tibial plateau fractures and pilon fractures), Periprosthetic fractures, Nonunions or malunions, History of previous knee surgery, History of preexisting knee pain, History of degenerative arthritis or inflammatory arthropathy, any evidence of degenerative changes of pre-operative knee radiographs, and any concomitant injury to that limb. Any contraindication to MRI imaging Retained stainless steel hardware proximal to the knee joint including, but not limited to prior knee replacement. Under age 18 at the time of presentation, pregnant or planning to become pregnant within the study period, or under the jurisdiction of the Department of Corrections. Inability to provide informed consent Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study Insurance or other circumstantial restriction that would prohibit or interfere with the subject's ability to receive follow up care at the PI's institution. Any condition, acute or chronic, that in the opinion of the attending physician or the Principal Investigator, would contraindicate participation in this study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: Suprapatellar Approach<br>Suprapatellar Approach to Intramedullary Nailing. Surgeons will be allowed to use any size intramedullary tibial nail through an suprapatellar incision and splitting the quadriceps tendon. | Procedure: Intramedullary nailing of the tibia<br>* Standard care surgery<br>|
| Active Comparator: Infrapatellar Approach<br>Infrapatellar Approach Intramedullary Nailing. Surgeons will be allowed to use any size intramedullary tibial nail through an infrapatellar incision using either a medial parapatellar approach or a transpatellar approach. The knee will then be scanned using T1Rho MRI at 2 weeks postoperatively and 6 months postoperatively. | Procedure: Intramedullary nailing of the tibia<br>* Standard care surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1Rho MRI to quantify patellofemoral cartilage changes after IM nailing of the tibia as a primary treatment for acute tibial fractures. | The difference in proteoglycan content of patellofemoral articular cartilage as quantified using spin lattice relaxation in a rotating frame (T1ρ MRI weighted image) at 6 months post-hospital discharge between two groups randomized to undergo either a suprapatellar or infrapatellar approach to tibial IM nailing. | Up to 6 months post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | The difference in quality of life outcomes (Medical Outcomes Study: 36-Item Short Form Survey) at 6 months post-hospital discharge between two groups randomized to undergo either a suprapatellar or infrapatellar approach to tibial IM nailing. | Pre-op, 2 week scan, 6 months post discharge | 
| SMFA | MFA46A Injury and Arthritis Survey | Pre-op, 2 week scan, 6 months post discharge |