Clinical trial NCT01284998: Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
Official title: Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Valgus
Hallux Varus
Vicious Callus on M1
Keywords: forefoot deformities
basal osteotomy
Lead sponsor: Integra LifeSciences Services
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who need a fixation of osteotomy of the basis of the first metatarsal.

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.


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

Primary outcomes:
measure: Rate of device related complications.
timeFrame: 12 months
measure: Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score
timeFrame: 12 months
Secondary outcomes:
measure: X rays evaluation
timeFrame: 3 and12 months
measure: Pain using a visual analog scale
timeFrame: 3 and 12 months
measure: Function assessment
timeFrame: 3 and 12 Months
measure: Clinical assessment
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique du Mont Louis
city: Byblos
country: Lebanon
facility: Centre Hospitalier universitaire Notre Dame de secours
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital
Study officials:
References: