Clinical Trial: Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
Brief 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.
Detailed Summary:
Sponsor: Integra LifeSciences Services
Current Primary Outcome:
- Rate of device related complications. [ Time Frame: 12 months ]
- Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- X rays evaluation [ Time Frame: 3 and12 months ]
- Pain using a visual analog scale [ Time Frame: 3 and 12 months ]
- Function assessment [ Time Frame: 3 and 12 Months ]
- Clinical assessment [ Time Frame: 3 and 12 months ]
Original Secondary Outcome: Same as current
Information By: Integra LifeSciences Services
Dates:
Date Received: January 26, 2011
Date Started: June 2009
Date Completion:
Last Updated: September 10, 2014
Last Verified: September 2014