NCT01284998

Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: Integra LifeSciences Services · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may be more indicated than the distal osteotomy as it allows to achieve a greater degree of correction. However, weight bearing forces on the head of the first metatarsal acting at a distance from the osteotomy site subject the construct to an important dorsiflexion stress. Fixation strength being the important consideration led to design the B-BOP® Lock plate, specifically dedicated to basal osteotomy of the first metatarsal, with the following characteristics: * plantar positioning to obtain the best stability and resistance while reducing the implant bulkiness; * anatomical shape adapted to the plantar curve of the first metatarsal. Taking advantages of the most appropriated anatomical site to implant the B-BOP® Lock plate directly on tension, it offers an innovative and unique basal osteotomy fixation solution. The B-BOP® Lock osteosynthesis plate benefits now of the Surfix locking screws technology. The purpose of this study is to collect and publish data from several centers, several users.

Conditions

• Hallux Valgus
• Hallux Varus
• Vicious Callus on M1

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-01-27
• Last updated: 2014-09-11

Locations

3 sites across 3 countries: France, Lebanon, United Kingdom