Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate

Hallux Valgus Clinical Trial

Official title:

Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284998
• Other study ID #: RECON-EMEA-07
• 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

• Hallux Valgus
• Hallux Varus
• Vicious Callus on M1

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