Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

IlluminOss Medical

Status: Completed

Conditions: Humerus Fracture Metastatic Bone Disease

Treatments: Device: Photodynamic Bone Stabilization System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02338492

14-03-PATHOLHUM-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 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. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

Photodynamic Bone Stabilization System

Experimental group

Description:

Photodynamic Bone Stabilization System (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