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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hallux Valgus, Hallux Varus, Vicious Callus on M1

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| B-BOP lock<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device related complications. |  | 12 months | 
| Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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forefoot deformities, basal osteotomy