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

NCT01284998 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2014-09-11

No results posted yet for this study

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

Sponsors & Collaborators

  • Integra LifeSciences Services

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • France
  • Lebanon
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01284998 on ClinicalTrials.gov