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

Completed

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

• Registration Number: NCT01284998
• Lead Sponsor: Integra LifeSciences Services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Centre Hospitalier universitaire Notre Dame de secours; 🇱🇧 Byblos, Lebanon

Wrexham Maelor Hospital; 🇬🇧 Wrexham, United Kingdom

Clinique du Mont Louis; 🇫🇷 Paris, France