search
Back to results

Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

Primary Purpose

Humerus Fracture Metastatic Bone Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photodynamic Bone Stabilization System
Sponsored by
IlluminOss Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humerus Fracture Metastatic Bone Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Stanford School of Medicine
  • MedStar Washington Hospital Center
  • Emory University School of Medicine
  • Midwest Orthopaedics at Rush
  • MedStar Franklin Square Medical Center
  • Hackensack University Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Duke University School of Medicine
  • Wake Forest Baptist Medical Center
  • The Ohio State University Wexner Medical Center
  • University of Pittsburgh Physicians
  • University Orthopedics Inc.
  • Marshall University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photodynamic Bone Stabilization System

Arm 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

Outcomes

Primary Outcome Measures

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).
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.
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

Secondary Outcome Measures

Pain at Palpation
Pain on palpation and clinical significance
Duration of Index Procedure
Duration of index procedure (hours)
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.
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.
Assessment of Post-Surgery Status
Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication
Summary of Procedure and Device-Related Complications Rate
Procedure and device-related complications rate presented at follow-up visits
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.
Length of Hospital Stay
Length of hospital stay (from day of procedure to day of discharge)

Full Information

First Posted
January 7, 2015
Last Updated
April 18, 2018
Sponsor
IlluminOss Medical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02338492
Brief Title
Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlluminOss Medical, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humerus Fracture Metastatic Bone Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photodynamic Bone Stabilization System
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Photodynamic Bone Stabilization System
Intervention Description
Treatment of impending and actual pathological fractures of the humerus
Primary Outcome Measure Information:
Title
Change in Pain
Description
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).
Time Frame
Baseline and 90 days
Title
Change in Function
Description
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.
Time Frame
Baseline and 90 days
Title
Summary of Clinical Safety Success
Description
No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation
Time Frame
Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360
Secondary Outcome Measure Information:
Title
Pain at Palpation
Description
Pain on palpation and clinical significance
Time Frame
90, 180 and 360 days
Title
Duration of Index Procedure
Description
Duration of index procedure (hours)
Time Frame
1 Day
Title
Activities of Daily Living Score Through All Follow-up Intervals
Description
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.
Time Frame
Baseline, 90, 180 and 360 days
Title
MSTS Upper Extremity Functional Outcome
Description
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.
Time Frame
90, 180, 360 days
Title
Assessment of Post-Surgery Status
Description
Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication
Time Frame
Surgery & Discharge, 7-14, 30, 90, 180, 360 days
Title
Summary of Procedure and Device-Related Complications Rate
Description
Procedure and device-related complications rate presented at follow-up visits
Time Frame
up to day 90, up to day180 since day 90, up to 360 since day 180
Title
Summary of Change From Baseline Range of Motion by Visit and Test
Description
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.
Time Frame
Baseline, 90, 180 and 360 Days
Title
Length of Hospital Stay
Description
Length of hospital stay (from day of procedure to day of discharge)
Time Frame
From day of procedure until the day of hospital discharge (up to 36 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - General Inclusion Criteria Skeletally mature adult males and females 18 years of age or older. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as: Postmenopausal for at least 1 year OR Documented oophorectomy or hysterectomy Surgically sterile OR 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 Patient, or his/her legally authorized representative, is able to understand and provide informed consent. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule. VAS Pain Score > 60mm on 100mm scale. -Impending Fracture-Specific Inclusion Criteria Documented presence of at least one metastatic lesion of the humerus. Mirels Criteria Score ≥ 8. (specific to the target humeral lesion and subject to minimum VAS score requirements) Destruction of cortical bone at impending fracture site > 50%. -Actual Fracture-Specific Inclusion Criteria Fracture is closed, Gustilo Type I or II. Exclusion Criteria: - General Exclusion Criteria Primary tumor (osteogenic origin, etc.) at site. 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. Active or incompletely treated infections that could involve the device implant site. Distant foci of infection that may spread to the implant site. Allergy to implant materials or dental glue. In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency). In the investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders. Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder). Prisoner -Impending Fracture-Specific Exclusion Criteria Mirels Score < 8 (specific to target humeral lesion). Destruction of cortical bone at impending fracture site < 50%. Prior surgery and/or prior fracture of affected site. Any articular component to impending fracture site. -Actual Fracture-Specific Exclusion Criteria Open fractures with severe contamination. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
Facility Information:
Facility Name
Stanford School of Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Midwest Orthopaedics at Rush
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
MedStar Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pittsburgh Physicians
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University Orthopedics Inc.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Marshall University
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

We'll reach out to this number within 24 hrs