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

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ClinicalTrials.gov Identifier: NCT02373904
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
IlluminOss Medical, Inc.

February 17, 2015
February 27, 2015
August 1, 2017
February 2015
December 2016   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT02373904 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease
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
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Humerus Pathological Fracture
Device: Photodynamic Bone Stabilization System
Treatment of impending and actual pathological fractures of the humerus
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.
Intervention: Device: Photodynamic Bone Stabilization System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
45
June 2017
December 2016   (Final data collection date for primary outcome measure)

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. Able to understand and provide informed consent.
  5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.

    -Impending Fracture-Specific Inclusion Criteria

  6. Documented presence of solitary metastatic lesion.
  7. Mirels Criteria Score ≥ 8.
  8. Destruction of cortical bone at impending fracture site > 50%.

    -Actual Fracture-Specific Inclusion Criteria

  9. Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A1, 11A2 and 11B1, 11B2 and 12A1,12A2 and 12B1, 12B2 and 13A1,13A2 and 13B1, 13B2.
  10. Fracture is closed, Gustilo Type I or IIA.

Exclusion Criteria:

-General Exclusion Criteria

  1. Primary tumor (osteogenic origin, etc.) at site.
  2. Impending fracture or actual fracture location other than humerus.
  3. Current concomitant traumatic fracture of any other location.
  4. Active or incompletely treated infections that could involve the device implant site.
  5. Distant foci of infection that may spread to the implant site.
  6. Allergy to implant materials or dental glue.
  7. Vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site.
  8. Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).

    -Impending Fracture-Specific Exclusion Criteria

  9. Mirels Score < 8.
  10. Destruction of cortical bone at impending fracture site < 50%.
  11. Prior surgery and/or prior fracture of affected site.
  12. Any articular component to impending fracture site.

    -Actual Fracture-Specific Exclusion Criteria

  13. Index treatment is greater than 28 days post fracture.
  14. Open fractures with severe contamination.
  15. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
  16. Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment
  17. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Netherlands
Italy
 
NCT02373904
14-03-PATHOLHUM-01
NL49653.072.14 ( Other Identifier: Institutional Review Board Nijmegen )
Not Provided
Not Provided
Not Provided
IlluminOss Medical, Inc.
IlluminOss Medical, Inc.
Not Provided
Not Provided
IlluminOss Medical, Inc.
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP