Status:
COMPLETED
T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Synthes USA HQ, Inc.
Conditions:
Acute Tibial Fracture Requiring Intramedullary Nailing
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief Summary
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 ap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01879215
Start Date
June 1 2013
End Date
July 1 2020
Last Update
July 22 2020
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104