Clinical Trial: 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 Hu

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 ]
    Change in VAS score
  • Functional improvement [ Time Frame: 90 days ]
    Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS)
  • Clinical safety success: No Serious Device Related Complications, No additional surgical interventions [ 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:

Current Secondary Outcome:

  • Clinical safety success [ Time Frame: 90, 180 and 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 and 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 ]
  • Activities of Daily Living score through all follow-up intervals [ Time Frame: 90, 180, 360 days ]
    Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) and EORTC QLQ BM22
  • Disability status [ Time Frame: 90, 180, 360 days ]
    Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS)
  • 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 Adverse Events [ Time Frame: 90, 180, 360 days ]
  • Incidence and number of procedure- and device-related complications [ Time Frame: 90, 180, 360 days ]


Original Secondary Outcome:

Information By: IlluminOss Medical, Inc.

Dates:
Date Received: January 7, 2015
Date Started: March 2015
Date Completion: September 2017
Last Updated: January 26, 2017
Last Verified: January 2017