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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services
ClinicalTrials.gov Identifier:
NCT01284998
First received: January 26, 2011
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by Integra LifeSciences Services:

Primary Outcome Measures:
  • Rate of device related complications. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Iprovement of American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • X rays evaluation [ Time Frame: 3 and12 months ] [ Designated as safety issue: No ]
  • Pain using a visual analog scale [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Function assessment [ Time Frame: 3 and 12 Months ] [ Designated as safety issue: No ]
  • Clinical assessment [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01284998     History of Changes
Other Study ID Numbers: RECON-EMEA-07
Study First Received: January 26, 2011
Last Updated: October 9, 2012
Health Authority: France: Institutional Ethical Committee
Lebanon: Institutional Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Integra LifeSciences Services:
forefoot deformities
basal osteotomy

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

ClinicalTrials.gov processed this record on May 19, 2013