Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hallux Valgus
- Sponsor
- Integra LifeSciences Services
- Enrollment
- 85
- Locations
- 3
- Primary Endpoint
- Rate of device related complications.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject of either gender who needs a fixation of osteotomy of the basis of the first metatarsal for whose surgeon has recommended that a B-BOP® Lock plate from INTEGRA be implanted can be enrolled in this study.
- •Age ≥ 18 years
- •Have willingness to give his/her data transfer authorisation
Exclusion Criteria
- •Contraindication of the implantation of the B-BOP Lock plate
- •History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
Outcomes
Primary Outcomes
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
Secondary Outcomes
- X rays evaluation(3 and12 months)
- Pain using a visual analog scale(3 and 12 months)
- Function assessment(3 and 12 Months)
- Clinical assessment(3 and 12 months)