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

IlluminOss Medical

Status: Completed

Conditions: Humerus Pathological Fracture

Treatments: Device: Photodynamic Bone Stabilization System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02373904

NL49653.072.14 (Other Identifier)

14-03-PATHOLHUM-01

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Photodynamic Bone Stabilization System (PBSS)

Experimental group

Description:

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.

Treatment:

Device: Photodynamic Bone Stabilization System