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OpenTrials
Completed

NCT Number: NCT02688296

Effectiveness Of The Fibulock Intramedullary Nail

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.

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Key information

Conditions

Fibula Fracture Fibula Fractures Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Health South Florida, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Fibulock

Device

Fibulock intramedullary implant will be used to repair fibula fractures

Primary outcomes

  1. Efficacy Assessment post implantation with Fibulock Intramedullary Nail assessed using lateral and mortice view x-rays

    Time frame: 26 weeks

    Lateral and mortice view x-rays at 26 weeks

Secondary outcomes

  1. Visual Analog Scale

    Time frame: 26 weeks and 52 weeks

    Patient self reported pain intensity.

  2. SF 12

    Time frame: 26 weeks and 52 weeks

    SF 12 is a Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view.

  3. Foot Function Index

    Time frame: 26 weeks and 52 weeks

    The Foot Function Index (FFI) is used to measure the impact of foot pathology on function in terms of pain, disability and activity restriction.

Sponsors and collaborators

Lead sponsor

Arthrex, Inc.

Industry

Registry information

Official study title

The Use Of A Fibular Intramedullary Nail For Fixation For Unstable Fibula Fractures

Acronym: Fibulock

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2016
Registry last updated
Jan 20, 2021

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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