An observational study in Hallux Valgus, Hallux Varus and Vicious Callus on M1, sponsored by Integra LifeSciences Services. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-11.
Sponsored by Integra LifeSciences Services · Observational
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:
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.
144 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.
This study's enrollment of 85 is above the median of 50 across 35 observational studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Integra LifeSciences Services is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who need a fixation of osteotomy of the basis of the first metatarsal.
Exclusion Criteria:
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
Rate of device related complications.
Time frame: 12 months
Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score
Time frame: 12 months
X rays evaluation
Time frame: 3 and12 months
Pain using a visual analog scale
Time frame: 3 and 12 months
Function assessment
Time frame: 3 and 12 Months
Clinical assessment
Time frame: 3 and 12 months
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Integra LifeSciences Services