NCT00429585

A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures

Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia fracture? Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

Detailed description

The study is a multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

Conditions

• Tibial Fractures

Interventions

Type	Name	Description
DEVICE	reamed, interlocking intramedullary nail	Standard of care device for tibia fracture repair; Randomized Treatment - Nail
DEVICE	locking periarticular plate	Standard of care device for tibia fracture repair; Randomized Treatment - Plate

Timeline

• Start date: 2007-02-01
• Primary completion: 2020-11-30
• Completion: 2020-12-16
• First posted: 2007-02-01
• Last updated: 2021-11-02
• Results posted: 2021-11-02

Locations

29 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study