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Completed

NCT Number: NCT00823251

IlluminOss Hand Fracture International Clinical Feasibility Study

The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital del Trabajador

Santiago, Chile

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Skeletally mature
  • Patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure
  • Female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours
  • Acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation
  • Fracture has occurred within past 3 weeks
  • Fracture types: transverse, short oblique, or any fracture pattern in which the comminuted segment is equal to or less than the diameter of the bone at fracture site

Exclusion criteria

  • Patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study
  • Patient has experienced a crush, mangling, or burn type injury
  • Patient has probable history of infection or confirmed infection at baseline
  • Patient has previous diagnosis of a significant bone disorder that may impair bone healing
  • Patient has a life expectancy of < 26 weeks
  • Pathological fracture secondary to tumor
  • Open fracture of Gustilo-Anderson Type II or III

Treatment and study plan

IlluminOss Device

Device

The IlluminOss™ Bone Stabilization System is designed to deliver the device to the fracture site via the medullary canal of the bone using percutaneous techniques. Once the device is in place and has spanned the fracture site, the device is expanded and hardened to reduce and stabilize the fracture, to aid in the support and healing of the bone fracture by primary callous formation and remodeling.

Primary outcomes

  1. Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.

    Time frame: Immediately post-surgery

Secondary outcomes

  1. Rate of Fracture Union

    Time frame: 180 day

  2. Rate of Anatomic Alignment

    Time frame: 180 Day

  3. Functionality Score

    Time frame: 180 Day

  4. Grip Strength

    Time frame: 180 Day

  5. Range of Motion

    Time frame: 180 day

  6. Incidence of Reintervention of Target Fracture

    Time frame: 180 Day

  7. Bone Pin Migration

    Time frame: 180 Day

  8. Adverse Event Rate

    Time frame: 180 day

Sponsors and collaborators

Lead sponsor

IlluminOss Medical, Inc.

Industry

Registry information

Official study title

IlluminOss Medical- Photodynamic Bone Stabilization System- International Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2013
First posted
Jan 15, 2009
Registry last updated
Jun 7, 2017

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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