- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01284998
Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France
- Clinique du Mont Louis
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Byblos, Lebanon
- Centre Hospitalier universitaire Notre Dame de secours
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Wrexham, United Kingdom
- Wrexham Maelor Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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B-BOP lock
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Rate of device related complications.
Time Frame: 12 months
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12 months
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Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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X rays evaluation
Time Frame: 3 and12 months
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3 and12 months
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Pain using a visual analog scale
Time Frame: 3 and 12 months
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3 and 12 months
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Function assessment
Time Frame: 3 and 12 Months
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3 and 12 Months
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Clinical assessment
Time Frame: 3 and 12 months
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3 and 12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECON-EMEA-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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