Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
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.
Vicious Callus on M1
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate|
- Rate of device related complications. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- X rays evaluation [ Time Frame: 3 and12 months ] [ Designated as safety issue: No ]
- Pain using a visual analog scale [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
- Function assessment [ Time Frame: 3 and 12 Months ] [ Designated as safety issue: No ]
- Clinical assessment [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Subjects who needs a fixation of osteotomy of the basis of the first metatarsal and for whose surgeon has recommended that a B-BOP® Lock plate from INTEGRA be implanted can be enrolled in this study
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284998
|Clinique du Mont Louis|
|Centre Hospitalier universitaire Notre Dame de secours|
|Wrexham Maelor Hospital|
|Wrexham, United Kingdom|