Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Tibial Fracture Requiring Intramedullary Nailing
- Sponsor
- University of Pennsylvania
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- T1Rho MRI to quantify patellofemoral cartilage changes after IM nailing of the tibia as a primary treatment for acute tibial fractures.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
T1Rho MRI to quantify patellofemoral cartilage changes after IM nailing of the tibia as a primary treatment for acute tibial fractures.
Time Frame: Up to 6 months post-discharge
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.
Secondary Outcomes
- SF-36(Pre-op, 2 week scan, 6 months post discharge)
- SMFA(Pre-op, 2 week scan, 6 months post discharge)