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Completed

NCT Number: 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.

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Key information

Conditions

Hallux Valgus Foot Deformities Hallux Varus Musculoskeletal Diseases Vicious Callus on M1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Mont Louis, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of device related complications.

    Time frame: 12 months

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

    Time frame: 12 months

Secondary outcomes

  1. X rays evaluation

    Time frame: 3 and12 months

  2. Pain using a visual analog scale

    Time frame: 3 and 12 months

  3. Function assessment

    Time frame: 3 and 12 Months

  4. Clinical assessment

    Time frame: 3 and 12 months

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Services

Industry

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2011
Registry last updated
Sep 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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