T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - 50
Updated:3/3/2019
Start Date:June 2013
End Date:March 2021
Contact:Brandon Eilberg, BS
Email:brandon.eilberg@uphs.upenn.edu
Phone:2152949167

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Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?

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.


Inclusion Criteria:

1. Isolated tibial shaft fractures indicated for intramedullary nailing,

2. Acute tibia fractures,

3. Closed or open tibia fractures,

4. Skeletally mature patient between the ages of 21 and 50,

5. No prior history of knee surgery,

6. No prior history of knee pain,

7. No history of degenerative joint disease or inflammatory arthropathy

8. Not pregnant or known to be under the jurisdiction of the Department of Corrections

9. Able to provide informed consent.

10. 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

11. Ability to communicate, read, and write in English

12. Intent of subject to receive follow up fracture care at the PI's institution.

Exclusion Criteria:

1. Tibial fractures requiring articular reconstruction (tibial plateau fractures and
pilon fractures),

2. Periprosthetic fractures,

3. Nonunions or malunions,

4. History of previous knee surgery,

5. History of preexisting knee pain,

6. History of degenerative arthritis or inflammatory arthropathy, any evidence of
degenerative changes of pre-operative knee radiographs, and any concomitant injury to
that limb.

7. Any contraindication to MRI imaging

8. Retained stainless steel hardware proximal to the knee joint including, but not
limited to prior knee replacement.

9. 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.

10. Inability to provide informed consent

11. Participation in any other medical device or medicinal product study within the
previous month that could influence the results of the present study

12. 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.

13. Any condition, acute or chronic, that in the opinion of the attending physician or the
Principal Investigator, would contraindicate participation in this study.
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Samir Mehta, MD
Phone: 215-294-9167
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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mi
from
Philadelphia, PA
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