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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01284998
First Posted: January 27, 2011
Last Update Posted: September 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Integra LifeSciences Services
  Purpose

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.


Condition
Hallux Valgus Hallux Varus Vicious Callus on M1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate

Further study details as provided by Integra LifeSciences Services:

Primary Outcome Measures:
  • Rate of device related complications. [ Time Frame: 12 months ]
  • Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • X rays evaluation [ Time Frame: 3 and12 months ]
  • Pain using a visual analog scale [ Time Frame: 3 and 12 months ]
  • Function assessment [ Time Frame: 3 and 12 Months ]
  • Clinical assessment [ Time Frame: 3 and 12 months ]

Enrollment: 85
Study Start Date: June 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who need a fixation of osteotomy of the basis of the first metatarsal.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284998


Locations
France
Clinique du Mont Louis
Paris, France
Lebanon
Centre Hospitalier universitaire Notre Dame de secours
Byblos, Lebanon
United Kingdom
Wrexham Maelor Hospital
Wrexham, United Kingdom
Sponsors and Collaborators
Integra LifeSciences Services
  More Information

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01284998     History of Changes
Other Study ID Numbers: RECON-EMEA-07
First Submitted: January 26, 2011
First Posted: January 27, 2011
Last Update Posted: September 11, 2014
Last Verified: September 2014

Keywords provided by Integra LifeSciences Services:
forefoot deformities
basal osteotomy

Additional relevant MeSH terms:
Hallux Valgus
Hallux Varus
Foot Deformities
Musculoskeletal Diseases