NCT03945669

Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures

Intramedullary Nailing Versus External Ring Fixation for Surgical Treatment of Tibial Shaft Fractures in Adults and Their One Year Outcome on Recovery: Study Protocol for a Pragmatic Randomized Controlled Trial (The IMVEX Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.

Detailed description

This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures. The primary aim of the project is to compare the one-year Knee Injury and Osteoarthritis Outcome Score - Sport (KOOS-Sport) after standard intramedullary nailing with external ring fixation for patients with tibial shaft fractures. The explorative aim is to report the effect of the two surgical procedures on the development of complications, time to bone union, pain reactions, muscle strength, activity of daily living and time to return to work.

Conditions

• Tibial Shaft Fracture

Interventions

Type	Name	Description
PROCEDURE	Intramedullary Nailing	fracture fixation of the tibial shaft fracture with an intramedullary nail.
PROCEDURE	External Ring fixation	fracture fixation of the tibial shaft fracture with an external ring fixator.

Timeline

• Start date: 2019-11-01
• Primary completion: 2024-06-24
• Completion: 2024-06-24
• First posted: 2019-05-10
• Last updated: 2024-06-25

Locations

3 sites across 1 country: Denmark