Clinical trial NCT02373904: A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humerus Pathological Fracture
Lead sponsor: IlluminOss Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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. 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.

Primary outcomes:
measure: Pain Reduction
timeFrame: 90 days
measure: 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)
timeFrame: 90 days
measure: Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals)
timeFrame: 90 days
measure: Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation)
timeFrame: 90 days
Secondary outcomes:
measure: Pain Reduction (VAS Pain Score change of > -33% compared to baseline)
timeFrame: 90, 180 and 360 days
measure: 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)
timeFrame: 90, 180, 360 days
measure: Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals)
timeFrame: 90, 180, 360 days
measure: Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation)
timeFrame: 90, 180, 360 days
measure: Duration of index procedure and length of hospital stay
timeFrame: 90, 180, 360 days
measure: Disability status
timeFrame: 90, 180, 360 days
measure: Evaluation of duration of physical therapy prescription
timeFrame: 90, 180, 360 days
measure: Assessment of prescription and over-the-counter analgesic medication use
timeFrame: 90, 180, 360 days
measure: Survivability from time of index procedure to death
timeFrame: 90, 180, 360 days
measure: Incidence and number of AEs
timeFrame: 90, 180, 360 days
measure: Incidence and number of procedure- and device-related complications
timeFrame: 90, 180, 360 days
measure: Activities of Daily Living score through all follow-up intervals
timeFrame: 90, 180, 360 days
measure: VAS Pain score from baseline through all follow-up intervals
timeFrame: 90, 180, 360 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Koln
country: Germany
facility: St. Vinzenz-Hospital GmbH
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Wetzlar
country: Germany
facility: Lahn-Dill Kliniken
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
Study officials:
References: