Clinical Trial: A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Prospective, Multi-Center Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pathological Fractures in the Humerus

Brief Summary: The purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.

Detailed Summary:
Sponsor: IlluminOss Medical, Inc.

Current Primary Outcome:

  • Pain Reduction [ Time Frame: 90 days ]
    VAS Pain Score change of > -33% compared to baseline
  • Functional Improvement (Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline) [ Time Frame: 90 days ]
    • Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline
    • EORTC QLQ-C30 improvement of > +10% from baseline
    • EORTC QLQ-BM22 improvement of > +10% from baseline
  • Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals) [ Time Frame: 90 days ]
    • No Serious Device Related Complications
    • No additional surgical interventions: revisions, supplements, fixations or removals
  • Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation) [ Time Frame: 90 days ]
    No device fracture, migrations, mal-alignment or loss of reduction or fixation


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain Reduction (VAS Pain Score change of > -33% compared to baseline) [ Time Frame: 90, 180 and 360 days ]
    VAS Pain Score change of > -33% compared to baseline
  • Functional Improvement (-Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline, -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline) [ Time Frame: 90, 180, 360 days ]
    • Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline,
    • EORTC QLQ-C30 improvement of > +10% from baseline
    • EORTC QLQ-BM22 improvement of > +10% from baseline
  • Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals) [ Time Frame: 90, 180, 360 days ]
    • No Serious Device Related Complications
    • No additional surgical interventions: revisions, supplements, fixations or removals
  • Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation) [ Time Frame: 90, 180, 360 days ]
    No device fracture, migrations, mal-alignment or loss of reduction or fixation
  • Duration of index procedure and length of hospital stay [ Time Frame: 90, 180, 360 days ]
  • Disability status [ Time Frame: 90, 180, 360 days ]
    Determined per Investigator assessment
  • Evaluation of duration of physical therapy prescription [ Time Frame: 90, 180, 360 days ]
  • Assessment of prescription and over-the-counter analgesic medication use [ Time Frame: 90, 180, 360 days ]
  • Survivability from time of index procedure to death [ Time Frame: 90, 180, 360 days ]
  • Incidence and number of AEs [ Time Frame: 90, 180, 360 days ]
  • Incidence and number of procedure- and device-related complications [ Time Frame: 90, 180, 360 days ]
  • Activities of Daily Living score through all follow-up intervals [ Time Frame: 90, 180, 360 days ]
    Barthel Index of Activities of Daily Living (ADLs), EORTC QLQ-C30 and EORTC QLQ-BM22
  • VAS Pain score from baseline through all follow-up intervals [ Time Frame: 90, 180, 360 days ]
    VAS pain scale


Original Secondary Outcome: Same as current

Information By: IlluminOss Medical, Inc.

Dates:
Date Received: February 17, 2015
Date Started: February 2015
Date Completion: March 2017
Last Updated: February 22, 2017
Last Verified: February 2017