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

NCT ID: NCT01284998

Last Updated: 2014-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-09-30

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.

Conditions

Hallux Valgus; Hallux Varus; Vicious Callus on M1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

B-BOP lock

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integra LifeSciences Services

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique du Mont Louis

Paris, , France

Centre Hospitalier universitaire Notre Dame de secours

Byblos, , Lebanon

Wrexham Maelor Hospital

Wrexham, , United Kingdom

Countries

France; Lebanon; United Kingdom

Other Identifiers

RECON-EMEA-07

Identifier Type: -

Identifier Source: org_study_id