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

NCT01284998 | Completed

• 1 other identifier: RECON-EMEA-07
• Study Type: observational
• Target: 85
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Hallux Valgus; Hallux Varus; Vicious Callus on M1

Keywords

forefoot deformities; basal osteotomy

Outcome Measures

Primary Outcomes (2)

• Rate of device related complications.

  12 months

• Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score

  12 months

Secondary Outcomes (4)

• X rays evaluation

  3 and12 months

• Pain using a visual analog scale

  3 and 12 months

• Function assessment

  3 and 12 Months

• Clinical assessment

  3 and 12 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who need a fixation of osteotomy of the basis of the first metatarsal.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Services: lead

Study Sites (3)

Clinique du Mont Louis

Paris, France

Location

Centre Hospitalier universitaire Notre Dame de secours

Byblos, Lebanon

Location

Wrexham Maelor Hospital

Wrexham, United Kingdom

Location

MeSH Terms

Conditions

Hallux Valgus; Hallux Varus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: June 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

GB (1); LE (1); FR (1)