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Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

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ClinicalTrials.gov Identifier: NCT02338492
Recruitment Status : Completed
First Posted : January 14, 2015
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Humerus Fracture Metastatic Bone Disease Device: Photodynamic Bone Stabilization System Not Applicable

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  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Pain [ Time Frame: 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).

  2. Change in Function [ Time Frame: 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.

  3. Summary of Clinical Safety Success [ Time Frame: 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 :
  1. Pain at Palpation [ Time Frame: 90, 180 and 360 days ]
    Pain on palpation and clinical significance

  2. Duration of Index Procedure [ Time Frame: 1 Day ]
    Duration of index procedure (hours)

  3. Activities of Daily Living Score Through All Follow-up Intervals [ Time Frame: 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.

  4. MSTS Upper Extremity Functional Outcome [ Time Frame: 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.

  5. Assessment of Post-Surgery Status [ Time Frame: Surgery & Discharge, 7-14, 30, 90, 180, 360 days ]
    Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication

  6. Summary of Procedure and Device-Related Complications Rate [ Time Frame: 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

  7. Summary of Change From Baseline Range of Motion by Visit and Test [ Time Frame: 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.

  8. Length of Hospital Stay [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338492


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

Documents provided by IlluminOss Medical, Inc.:
Study Protocol  [PDF] January 6, 2016
Statistical Analysis Plan  [PDF] November 15, 2016


Responsible Party: IlluminOss Medical, Inc.
ClinicalTrials.gov Identifier: NCT02338492     History of Changes
Other Study ID Numbers: 14-03-PATHOLHUM-02
First Posted: January 14, 2015    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Fractures, Bone
Bone Diseases
Humeral Fractures
Fractures, Spontaneous
Wounds and Injuries
Musculoskeletal Diseases
Arm Injuries