Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

Not Applicable

Completed

• Conditions: Humerus Fracture Metastatic Bone Disease
• Interventions: Device: Photodynamic Bone Stabilization System

• Registration Number: NCT02338492
• Lead Sponsor: IlluminOss Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-14
• Study Start: 2015-03
• Primary Completion: 2016-10
• Study Completion: 2017-07
• Disposition First Submitted: 2017-11-13
• Disposition First Submitted QC: 2017-11-13
• Disposition First Posted: 2017-11-17
• Results First Submitted: 2018-01-15
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-18
• Last Update Submitted: 2018-04-18
• Results First Posted: 2018-05-17
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photodynamic Bone Stabilization System	Photodynamic Bone Stabilization System	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

Primary Outcome Measures

Name	Time	Method
Change in Pain	Baseline and 90 days	Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain).
Change in Function	Baseline and 90 days	Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.
Summary of Clinical Safety Success	Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360	No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation

Secondary Outcome Measures

Name	Time	Method
MSTS Upper Extremity Functional Outcome	90, 180, 360 days	Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.
Assessment of Post-Surgery Status	Surgery & Discharge, 7-14, 30, 90, 180, 360 days	Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication
Activities of Daily Living Score Through All Follow-up Intervals	Baseline, 90, 180 and 360 days	Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning.
Summary of Procedure and Device-Related Complications Rate	up to day 90, up to day180 since day 90, up to 360 since day 180	Procedure and device-related complications rate presented at follow-up visits
Summary of Change From Baseline Range of Motion by Visit and Test	Baseline, 90, 180 and 360 Days	Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm.
Pain at Palpation	90, 180 and 360 days	Pain on palpation and clinical significance
Duration of Index Procedure	1 Day	Duration of index procedure (hours)
Length of Hospital Stay	From day of procedure until the day of hospital discharge (up to 36 days)	Length of hospital stay (from day of procedure to day of discharge)

Trial Locations

Locations (13)

MedStar Franklin Square Medical Center; 🇺🇸 Baltimore, Maryland, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Stanford School of Medicine; 🇺🇸 Redwood City, California, United States

Midwest Orthopaedics at Rush; 🇺🇸 Chicago, Illinois, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Duke University School of Medicine; 🇺🇸 Durham, North Carolina, United States

University Orthopedics Inc.; 🇺🇸 Providence, Rhode Island, United States

University of Pittsburgh Physicians; 🇺🇸 Pittsburgh, Pennsylvania, United States

Marshall University; 🇺🇸 Huntington, West Virginia, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States