Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study
Completed · Not applicable
Conditions studied: Tibial Fractures
In brief
This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.
Key facts
- Study ID
- NCT01341418
- Run by
- Florida Orthopaedic Institute
- People needed
- 40
- Starts
- 2011-04-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-02-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming
- Acute tibial fractures within 4 weeks of injury
- Closed or open tibial fractures after appropriate irrigation and debridement
- Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia
- Skeletally mature patient
- Age 18 and above.
You may not qualify if…
- Tibial shaft fractures that require articular reconstruction with plates
- Any tibial fracture extending > 1 cm into the proximal or distal 1/5 of tibia
- Tibial plateau fractures
- Pilon fractures
- Periprosthetic fractures
- Non-unions
- Prior knee surgery
- History of gout or rheumatoid or osteoarthritis
- Concomitant injury to same limb (including any traumatic injury to ipsilateral knee, femur or foot, and knee dislocation)
- Spinal injury
- Prisoner or high likelihood of incarceration
- Not likely to follow-up in the estimation of surgeon
- Pregnant females
Where it is running
- Tampa General Hospital — Tampa, Florida, United States
- St. Josephs Hospital — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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