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

Not Applicable

Completed

• Conditions: Humerus Pathological Fracture
• Interventions: Device: Photodynamic Bone Stabilization System

• Registration Number: NCT02373904
• Lead Sponsor: IlluminOss Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-02-27
• Primary Completion: 2016-12
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photodynamic Bone Stabilization System (PBSS)	Photodynamic Bone Stabilization System	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.

Primary Outcome Measures

Name	Time	Method
Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals)	90 days	* No Serious Device Related Complications; * No additional surgical interventions: revisions, supplements, fixations or removals
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)	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
Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation)	90 days	No device fracture, migrations, mal-alignment or loss of reduction or fixation
Pain Reduction	90 days	VAS Pain Score change of \> -33% compared to baseline

Secondary Outcome Measures

Name	Time	Method
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)	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
Disability status	90, 180, 360 days	Determined per Investigator assessment
Assessment of prescription and over-the-counter analgesic medication use	90, 180, 360 days
Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation)	90, 180, 360 days	No device fracture, migrations, mal-alignment or loss of reduction or fixation
Pain Reduction (VAS Pain Score change of > -33% compared to baseline)	90, 180 and 360 days	VAS Pain Score change of \> -33% compared to baseline
Duration of index procedure and length of hospital stay	90, 180, 360 days
Evaluation of duration of physical therapy prescription	90, 180, 360 days
Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals)	90, 180, 360 days	* No Serious Device Related Complications; * No additional surgical interventions: revisions, supplements, fixations or removals
Survivability from time of index procedure to death	90, 180, 360 days
Incidence and number of AEs	90, 180, 360 days
VAS Pain score from baseline through all follow-up intervals	90, 180, 360 days	VAS pain scale
Incidence and number of procedure- and device-related complications	90, 180, 360 days
Activities of Daily Living score through all follow-up intervals	90, 180, 360 days	Barthel Index of Activities of Daily Living (ADLs), EORTC QLQ-C30 and EORTC QLQ-BM22

Trial Locations

Locations (6)

Medical University of Vienna; 🇦🇹 Vienna, Austria

St. Vinzenz-Hospital GmbH; 🇩🇪 Koln, Germany

Lahn-Dill Kliniken; 🇩🇪 Wetzlar, Germany

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Medical Center Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany