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

Integra LifeSciences

Status: Completed

Conditions: Hallux Valgus; Hallux Varus; Vicious Callus on M1

Study type: Observational

Funder types: Industry

Identifiers

NCT01284998

RECON-EMEA-07

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

85 participants in 1 patient group

B-BOP lock

Description:

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