Safety and Efficacy Study of the Treatment of Humerus Fractures

IlluminOss Medical, Inc.44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Humerus Fractures

Interventions

Photodynamic Bone Stabilization SystemDEVICE

Treatment of acute humerus fractures

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Fracture-Specific Inclusion Criteria 1. Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A2, 11A3 and 11B1, 11B2 and 12A1, 12A2, 12A3 and 12B1, 12B2 (The Netherlands); AO Classification 11A1, 11A2, 11A3 and 11B1, 11B2 and 12A1, 12A2, 12A3 and 12B1, 12B2 and 13A1, 13A2 and 13B1, 13B2 (Germany). 2. Fracture is closed, Gustilo Type I or II. General Inclusion Criteria 3. Skeletally mature men and women, 50 years of age or older (The Netherlands only) or 61 years of age or older (Germany only) at time of index injury. 4. a) Female patients of child bearing potential agree to use double barrier method of contraception (The Netherlands only) b) Female patients of non-child bearing potential must meet one of the following criteria (The Netherlands only): * Postmenopausal for at least 1 year, or * Documented oophorectomy or hysterectomy, or * Surgically sterile 5. Willing and able to understand and sign the informed consent. Fracture-Specific Exclusion Criteria 1. Index treatment is greater than 28 days (The Netherlands only) or 14 days (Germany only) post fracture 2. Open fractures with severe contamination. 3. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable. 4. Marked bone loss or bone resorption patients, who due to a prior delayed union or non-union of the bones or other illnesses, may not be able to have their fracture adequately reduced prior to placement of the IlluminOss-device. This could leave bone void spaces that would preclude the device from maintaining alignment of the fractured bone. 5. Previous fracture of affected limb. General Exclusion Criteria 6. Pregnant or lactating (The Netherlands only). 7. Patients with a contralateral fracture of the forearm or humerus (Germany only). 8. Active or incompletely treated infections that could involve the site where the device will be implanted. 9. Distant foci of infections that may spread to the implant site 10. Uncooperative patients or patients, who are incapable of following directions (for example as a consequence of a neurological or psychiatric disorder). 11. Concomitant metabolic disorders that may impair bone formation. 12. Osteomalacia. 13. Allergic to implant materials or dental glue. 14. Vascular insufficiency, muscular atrophy, or neuro-muscular disease. 15. Polytrauma patients (multiple injuries resulting from a high-impact event, eg- a motor vehicle accident). 16. Life expectancy less than one year due to concurrent illness.

Locations (6)

St. Vinzenz-Hospital GmbH

Cologne, Germany

Klinikum Oberberg GmbH

Gummersbach, Germany

Lahn-Dill Kliniken

Wetzlar, Germany

Amphia Hospital

Breda, Netherlands

Outcomes

Primary Outcomes

Normal Radiographic Fracture Healing

Two of four cortices or two of four views demonstrating bridging on standard radiographs

Time frame: 180 days

Secondary Outcomes

Evaluation of Complete Radiographic Healing

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

Time frame: 180 and 360 days

Evaluation of Normal Radiographic Healing

Two of four cortices or two of four views demonstrating bridging on standard radiographs

Time frame: 360 days

Summary of Pain VAS

Change from baseline of pain visual analog score (VAS). Participants indicate their pain level by marking a point along a continuous horizontal line anchored by "No Pain" and "Severe Pain. Total score range: 0 to 100 units on a scale 0 = No pain 100 = Severe pain. Lower scores represent a better outcome (less pain), while higher scores represent a worse outcome (greater pain)

Time frame: 180 and 360 days

Summary of DASH Score

Change from baseline of disability of the arm shoulder and hand (DASH) score. DASH Disability/Symptom Total Score range: 0 to 100 units on a scale 0 = No disability/symptoms; 100 = Most severe disability/symptoms. Each item is scored on a 5-point Likert scale. Lower scores represent a better outcome (less disability and fewer symptoms), while higher scores represent a worse outcome (greater disability and more severe symptoms)

Time frame: 180 and 360 days

Summary of Constant Shoulder Score

Change from baseline of constant shoulder score. Total Constant Score range: 0 to 100 units on a scale 0 = Worst shoulder function; 100 = Best shoulder function. The total Constant Score is calculated by summing the four subscale scores for a maximum of 100 points. Higher scores represent a better outcome (improved shoulder function and less pain), while lower scores represent a worse outcome (greater disability and impaired shoulder function).

Data from ClinicalTrials.gov

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