Safety and Efficacy Study of the Treatment of Humerus Fractures

Not Applicable

• Conditions: Acute Humerus Fractures
• Interventions: Device: Photodynamic Bone Stabilization System

• Registration Number: NCT02394080
• Lead Sponsor: IlluminOss Medical, Inc.

Brief Summary

The purpose of this study is to collect safety and performance data on the use of the Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and alignment for the treatment of acute humerus fractures.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Primary Completion: 2017-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photodynamic Bone Stabilization System (PBSS)	Photodynamic Bone Stabilization System	The 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
Normal radiographic fracture healing	180 days	Two of four cortices or two of four views demonstrating bridging on standard radiographs

Secondary Outcome Measures

Name	Time	Method
Assessment of the procedure- and device-related complication rate	180 and 360 days
Evaluation of normal radiographic healing	360 days	Two of four cortices or two of four views demonstrating bridging on standard radiographs
Comparison of pain visual analog score (VAS) from baseline to all follow up intervals	180 and 360 days
Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals	180 and 360 days
Assessment of the incidence of adverse events	180 and 360 days
Evaluation of complete radiographic healing	180 and 360 days	Three of four cortices or three of four views demonstrating bridging, with dissolution of the majority (greater than or equal to 75% on orthogonal views) of fracture lines
Comparison of Constant shoulder score from baseline to all follow up intervals	180 and 360 days
Assessment of range of motion	180 and 360 days	Clinical assessment
Assessment of disability status	180 and 360 days	Per Investigator assessment
Assessment of return to work status	180 and 360 days
Assessment of no pain at palpation status	180 and 360 days	Clinical assessment
Assessment of return to pre-fracture mobility status	180 and 360 days	Clinical assessment

Trial Locations

Locations (3)

Amphia Hospital; 🇳🇱 Breda, Netherlands

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands

Albert Schweitzer Hospital; 🇳🇱 Dordrecht, Netherlands