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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
IlluminOss Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02338492
First received: January 7, 2015
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Humerus Fracture Metastatic Bone Disease Device: Photodynamic Bone Stabilization System (PBSS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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 From Metastatic Bone Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: March 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photodynamic Bone Stabilization System (PBSS)
The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone
Device: Photodynamic Bone Stabilization System (PBSS)
Treatment of impending and actual pathological fractures of the humerus

  Eligibility

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

Inclusion Criteria:

- General Inclusion Criteria

  1. Skeletally mature adult males and females 18 years of age or older.
  2. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.
  3. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as:

    1. Postmenopausal for at least 1 year OR
    2. Documented oophorectomy or hysterectomy
    3. Surgically sterile OR
    4. If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
  4. Patient, or his/her legally authorized representative, is able to understand and provide informed consent.
  5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
  6. VAS Pain Score > 60mm on 100mm scale.

    -Impending Fracture-Specific Inclusion Criteria

  7. Documented presence of at least one metastatic lesion of the humerus.
  8. Mirels Criteria Score ≥ 8. (specific to the target humeral lesion and subject to minimum VAS score requirements)
  9. Destruction of cortical bone at impending fracture site > 50%.

    -Actual Fracture-Specific Inclusion Criteria

  10. Fracture is closed, Gustilo Type I or II.

Exclusion Criteria:

- General Exclusion Criteria

  1. Primary tumor (osteogenic origin, etc.) at site.
  2. Impending or actual fracture at any other location that, in the Investigator's opinion, would preclude ability to assess pain and/or function in the target humerus.
  3. Active or incompletely treated infections that could involve the device implant site.
  4. Distant foci of infection that may spread to the implant site.
  5. Allergy to implant materials or dental glue.
  6. In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency).
  7. In the investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders.
  8. Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).
  9. Prisoner

    -Impending Fracture-Specific Exclusion Criteria

  10. Mirels Score < 8 (specific to target humeral lesion).
  11. Destruction of cortical bone at impending fracture site < 50%.
  12. Prior surgery and/or prior fracture of affected site.
  13. Any articular component to impending fracture site.

    -Actual Fracture-Specific Exclusion Criteria

  14. Open fractures with severe contamination.
  15. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
  16. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
  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: NCT02338492

Locations
United States, California
Stanford School of Medicine
Redwood City, California, United States, 94063
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
United States, Illinois
Midwest Orthopaedics at Rush
Chicago, Illinois, United States, 60612
United States, Maryland
MedStar Franklin Square Medical Center
Baltimore, Maryland, United States, 21237
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27710
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Physicians
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
University Orthopedics Inc.
Providence, Rhode Island, United States, 02905
United States, West Virginia
Marshall University
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
IlluminOss Medical, Inc.
  More Information

Responsible Party: IlluminOss Medical, Inc.
ClinicalTrials.gov Identifier: NCT02338492     History of Changes
Other Study ID Numbers: 14-03-PATHOLHUM-02
Study First Received: January 7, 2015
Last Updated: January 26, 2017

Additional relevant MeSH terms:
Fractures, Bone
Bone Diseases
Humeral Fractures
Fractures, Spontaneous
Wounds and Injuries
Musculoskeletal Diseases
Arm Injuries

ClinicalTrials.gov processed this record on June 23, 2017