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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01284998
Other study ID # RECON-EMEA-07
Secondary ID
Status Completed
Phase N/A
First received January 26, 2011
Last updated September 10, 2014
Start date June 2009
Est. completion date September 2012

Study information

Verified date September 2014
Source Integra LifeSciences Services
Contact n/a
Is FDA regulated No
Health authority France: Institutional Ethical CommitteeLebanon: Institutional Review BoardUnited Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Clinique du Mont Louis Paris
Lebanon Centre Hospitalier universitaire Notre Dame de secours Byblos
United Kingdom Wrexham Maelor Hospital Wrexham

Sponsors (1)

Lead Sponsor Collaborator
Integra LifeSciences Services

Countries where clinical trial is conducted

France,  Lebanon,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of device related complications. 12 months Yes
Primary Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score 12 months No
Secondary X rays evaluation 3 and12 months No
Secondary Pain using a visual analog scale 3 and 12 months No
Secondary Function assessment 3 and 12 Months No
Secondary Clinical assessment 3 and 12 months No
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