NCT03881241

Safety Study of Treatment of Leg Fractures

Multicenter, Post-market Observational Study Evaluating Safety and Efficacy of the EVOS SMALL Plating System for the Treatment of Lower Extremity Fractures

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.

Detailed description

This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the EVOS SMALL Plating System in subjects with proximal or distal (pilon or ankle) tibial fractures. Subjects will be recruited in the hospital emergency room or surgical department, at the point of identification of the need for ORIF surgery, and the decision is made to use the EVOS SMALL Plating System. The choice of medical and surgical treatment will be made independently by the Investigator in the regular course of practice and will not be influenced by this study protocol. Approximately 100 subjects will be enrolled in order to ensure at least 90 evaluable subjects, with a minimum of 45 evaluable subjects having either a) proximal or b) distal tibial fractures. Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative fracture resolution according to standard radiological practice (X-rays), clinical complications, reoperation rate, DRI, EQ-5D-5L, and pain VAS.

Conditions

• Tibial Fractures

Timeline

• Start date: 2019-09-20
• Primary completion: 2020-03-24
• Completion: 2020-03-24
• First posted: 2019-03-19
• Last updated: 2020-04-10

Locations

2 sites across 1 country: United States