Clinical trial NCT02338492: Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus
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 Fracture Metastatic Bone Disease
Lead sponsor: IlluminOss Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 81
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: This study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic cancer.

Detailed description: This is a prospective, multi-center, open label study to evaluate the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic malignancy.

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. 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.

Primary outcomes:
measure: Change in Pain
timeFrame: Baseline and 90 days
measure: Change in Function
timeFrame: Baseline and 90 days
measure: Summary of Clinical Safety Success
timeFrame: Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360
Secondary outcomes:
measure: Pain at Palpation
timeFrame: 90, 180 and 360 days
measure: Duration of Index Procedure
timeFrame: 1 Day
measure: Activities of Daily Living Score Through All Follow-up Intervals
timeFrame: Baseline, 90, 180 and 360 days
measure: MSTS Upper Extremity Functional Outcome
timeFrame: 90, 180, 360 days
measure: Assessment of Post-Surgery Status
timeFrame: Surgery & Discharge, 7-14, 30, 90, 180, 360 days
measure: Summary of Procedure and Device-Related Complications Rate
timeFrame: up to day 90, up to day180 since day 90, up to 360 since day 180
measure: Summary of Change From Baseline Range of Motion by Visit and Test
timeFrame: Baseline, 90, 180 and 360 Days
measure: Length of Hospital Stay
timeFrame: From day of procedure until the day of hospital discharge (up to 36 days)
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford School of Medicine
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Baltimore
country: United States
facility: MedStar Franklin Square Medical Center
state: Maryland
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Physicians
state: Pennsylvania
city: Providence
country: United States
facility: University Orthopedics Inc.
state: Rhode Island
city: Huntington
country: United States
facility: Marshall University
state: West Virginia
Study officials:
References: