Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
|ClinicalTrials.gov Identifier: NCT01284998|
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : September 11, 2014
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.
|Condition or disease|
|Hallux Valgus Hallux Varus Vicious Callus on M1|
|Study Type :||Observational|
|Actual Enrollment :||85 participants|
|Official Title:||Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate|
|Study Start Date :||June 2009|
|Primary Completion Date :||September 2012|
|Study Completion Date :||September 2012|
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284998
|Clinique du Mont Louis|
|Centre Hospitalier universitaire Notre Dame de secours|
|Wrexham Maelor Hospital|
|Wrexham, United Kingdom|