NCT01341418

Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Florida Orthopaedic Institute · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients undergoing tibial fracture repair will be consented and randomized into one of the two techniques, with arthroscopic photos taken before and after nail insertion to study the condition of the patello-femoral cartilage. Enrolled patients will be followed for one year in clinic.

Conditions

• Tibial Fractures

Interventions

Type	Name	Description
PROCEDURE	Suprapatellar approach	Suprapatellar surgical approach will be used for intramedullary nailing of tibial fractures. Arthroscopic photos will be obtained before and after nail insertion. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.
PROCEDURE	Infrapatellar approach	The Infrapatellar surgical approach will be used for intramedullary nailing of tibial fractures. No arthroscopic examination for this intervention. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-01-01
• Completion: 2016-01-01
• First posted: 2011-04-25
• Last updated: 2017-02-14

Locations

2 sites across 1 country: United States