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IlluminOss Hand Fracture International Clinical Feasibility Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IlluminOss Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00823251
First received: December 30, 2008
Last updated: June 6, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Orthopedic Fractures Device: IlluminOss device Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: IlluminOss Medical- Photodynamic Bone Stabilization System- International Study

Resource links provided by NLM:


Further study details as provided by IlluminOss Medical, Inc.:

Primary Outcome Measures:
  • Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location. [ Time Frame: Immediately post-surgery ]

Secondary Outcome Measures:
  • Rate of Fracture Union [ Time Frame: 180 day ]
  • Rate of Anatomic Alignment [ Time Frame: 180 Day ]
  • Functionality Score [ Time Frame: 180 Day ]
  • Grip Strength [ Time Frame: 180 Day ]
  • Range of Motion [ Time Frame: 180 day ]
  • Incidence of Reintervention of Target Fracture [ Time Frame: 180 Day ]
  • Bone Pin Migration [ Time Frame: 180 Day ]
  • Adverse Event Rate [ Time Frame: 180 day ]

Enrollment: 4
Study Start Date: December 2008
Study Completion Date: February 2013
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IlluminOss device
IlluminOss bone-pin device
Device: IlluminOss 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823251

Locations
Chile
Hospital del Trabajador
Santiago, Chile
Sponsors and Collaborators
IlluminOss Medical, Inc.
  More Information

Responsible Party: IlluminOss Medical, Inc.
ClinicalTrials.gov Identifier: NCT00823251     History of Changes
Other Study ID Numbers: ILLUM-OUS-2008-001
Study First Received: December 30, 2008
Last Updated: June 6, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on June 26, 2017