Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

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

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.

Study Overview

• Status: Completed
• Conditions: Humerus Fracture Metastatic Bone Disease
• Intervention / Treatment: Device: Photodynamic Bone Stabilization System

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford School of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Midwest Orthopaedics at Rush
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • MedStar Franklin Square Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University School of Medicine
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Physicians
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • University Orthopedics Inc.
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Photodynamic Bone Stabilization System; Treatment of impending and actual pathological fractures of the humerus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	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).	Baseline and 90 days
Change in Function	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.	Baseline and 90 days
Summary of Clinical Safety Success	No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation	Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at Palpation	Pain on palpation and clinical significance	90, 180 and 360 days
Duration of Index Procedure	Duration of index procedure (hours)	1 Day
Activities of Daily Living Score Through All Follow-up Intervals	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.	Baseline, 90, 180 and 360 days
MSTS Upper Extremity Functional Outcome	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.	90, 180, 360 days
Assessment of Post-Surgery Status	Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication	Surgery & Discharge, 7-14, 30, 90, 180, 360 days
Summary of Procedure and Device-Related Complications Rate	Procedure and device-related complications rate presented at follow-up visits	up to day 90, up to day180 since day 90, up to 360 since day 180
Summary of Change From Baseline Range of Motion by Visit and Test	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.	Baseline, 90, 180 and 360 Days
Length of Hospital Stay	Length of hospital stay (from day of procedure to day of discharge)	From day of procedure until the day of hospital discharge (up to 36 days)

Collaborators and Investigators

• Sponsor: IlluminOss Medical, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Arm Injuries; Fractures, Bone; Bone Diseases; Fractures, Spontaneous; Humeral Fractures
• Other Study ID Numbers: 14-03-PATHOLHUM-02