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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01284998

Enrollment

Registered

2011-01-27

Start date

2009-06-30

Completion date

2012-09-30

Last updated

2014-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus, Hallux Varus, Vicious Callus on M1

Keywords

forefoot deformities, basal osteotomy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

France, Lebanon, United Kingdom

Outcome results