Clinical trial NCT01879215: T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing
Official title: Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Tibial Fracture Requiring Intramedullary Nailing
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Synthes USA HQ, Inc.
First posted: 2013-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 approach. Subjects will be randomized to one or the other standard care surgical approaches.


Eligibility criteria: 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.

Primary outcomes:
measure: T1Rho MRI to quantify patellofemoral cartilage changes after IM nailing of the tibia as a primary treatment for acute tibial fractures.
timeFrame: Up to 6 months post-discharge
Secondary outcomes:
measure: SF-36
timeFrame: Pre-op, 2 week scan, 6 months post discharge
measure: SMFA
timeFrame: Pre-op, 2 week scan, 6 months post discharge
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Samir Mehta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Derek Donegan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Annamarie Horan, PhD
role: STUDY_DIRECTOR
References: