Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

NCT02338492 | Completed Results

• 1 other identifier: 14-03-PATHOLHUM-02
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 13

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.

Conditions

Humerus Fracture Metastatic Bone Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Pain at Palpation

  90, 180 and 360 days

• Duration of Index Procedure

  1 Day

• Activities of Daily Living Score Through All Follow-up Intervals

  Baseline, 90, 180 and 360 days

• MSTS Upper Extremity Functional Outcome

  90, 180, 360 days

• Assessment of Post-Surgery Status

  Surgery & Discharge, 7-14, 30, 90, 180, 360 days

Study Arms (1)

Photodynamic Bone Stabilization System

EXPERIMENTAL

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

Interventions

Photodynamic Bone Stabilization System DEVICE

Treatment of impending and actual pathological fractures of the humerus

Photodynamic Bone Stabilization System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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%.
• Fracture is closed, Gustilo Type I or II.

You may not qualify if:

• 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
• 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.
• Open fractures with severe contamination.
• Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.

Sponsors & Collaborators

• IlluminOss Medical, Inc.: lead

Study Sites (13)

Stanford School of Medicine

Redwood City, California, 94063, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30329, United States

Location

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

Location

MedStar Franklin Square Medical Center

Baltimore, Maryland, 21237, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Physicians

Pittsburgh, Pennsylvania, 15232, United States

Location

University Orthopedics Inc.

Providence, Rhode Island, 02905, United States

Location

Marshall University

Huntington, West Virginia, 25701, United States

Location

Results Point of Contact

• Title: Gene DiPoto
• Organization: IlluminOss Medical Inc.

gdipoto@illuminoss.com

401-714-0008

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 14, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: July 1, 2017
• Last Updated: May 17, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-04

Locations

US (13)