Effectiveness Of The Fibulock Intramedullary Nail

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Arthrex

Status

Completed

Conditions

Fibula Fracture

Treatments

Device: Fibulock

Study type

Observational

Funder types

Industry

Identifiers

NCT02688296
FIB-001

Details and patient eligibility

About

The objective of this post-market clinical study is to evaluate efficacy outcomes and complication rates in patients who have received the Fibulock™ Intramedullary Nail.

Full description

This is a retrospective/prospective, multi-site observational study, designed to evaluate the clinical outcomes and complication rates in subjects who were previously implanted with a Fibulock™ intramedullary nail. Patients will be screened for eligibility and subgroupings. Informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Sites will be asked to enroll subjects according to past treatment, with the Fibulock™ intramedullary nail for unstable fibula fracture. The sites will enroll subjects in the study based on inclusion/exclusion criteria. Patient pre-operative, intra-operative and post-operative records will be reviewed retrospectively. Once enrolled, subjects will undergo an evaluation of fracture outcome and complete a VAS pain score, SF-12, and Foot Function Index at 26 weeks and again at 52 weeks post-treatment.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • An unstable fibula fracture.
  • Must be less than 31 weeks post-implantation
  • Must have received surgical treatment with the Fibulock Intramedullary Nail for their unstable fibula - fracture
  • Male or female greater than or equal to 18 years of age and skeletally mature.
  • Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
  • Ability to understand and provide written authorization for use and disclosure of personal health information.

Exclusion criteria

  • Patients who are not implanted with a Sonoma Fibulock IM Nail

Trial design

34 participants in 3 patient groups

Pilon Fractures
Description:
Patients who are implanted with Fibulock and have a Pilon fracture
Treatment:
Device: Fibulock
High Risk Patients
Description:
Patients who are implanted with Fibulock and are at high risk of complications from ankle surgery due to conditions such as diabetes, advanced age or osteoporosis
Treatment:
Device: Fibulock
Otherwise Healthy Patients
Description:
Patients implanted with Fibulock who are healthy other than their ankle fracture
Treatment:
Device: Fibulock

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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