NCT02374944

Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).

Detailed description

Eligible patients will be randomized to one of two treatment arms: Hardware removal at 6 months or Hardware retention for a minimum of 2 years. Consenting patients having previously undergone open reduction and internal fixation of Lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms: removal hardware (RH) or hardware retention (HR). Outcome will be assessed at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years from enrollment.

Conditions

• Closed Fracture Dislocation, Tarsometatarsal Joint
• Open Fracture Dislocation, Tarsometatarsal Joint

Interventions

Type	Name	Description
PROCEDURE	Hardware removal	Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.

Timeline

• Start date: 2018-01-23
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2015-03-02
• Last updated: 2022-11-09

Locations

3 sites across 1 country: Canada