T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

Completed · Not applicable

Conditions studied: Acute Tibial Fracture Requiring Intramedullary Nailing

In brief

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.

Key facts

Study ID

NCT01879215

Run by

University of Pennsylvania

People needed

30

Starts

2013-06-01

Expected to finish

2020-07-01

Last updated by the study team

2020-07-22

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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