Acute Humerus FracturesNCT02394080
Safety and Efficacy Study of the Treatment of Humerus Fractures
A study testing Photodynamic Bone Stabilization System in people with Acute Humerus Fractures, run by IlluminOss Medical, Inc. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Acute Humerus Fractures
- What is being tested?
- Photodynamic Bone Stabilization System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Feb 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Fracture-Specific Inclusion Criteria
- 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).
- Fracture is closed, Gustilo Type I or II. General Inclusion Criteria
- 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.
- 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
- Willing and able to understand and sign the informed consent.
Fracture-Specific Exclusion Criteria
- Index treatment is greater than 28 days (The Netherlands only) or 14 days (Germany only) post fracture
- Open fractures with severe contamination.
- Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
- 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.
- Previous fracture of affected limb. General Exclusion Criteria
- Pregnant or lactating (The Netherlands only).
- Patients with a contralateral fracture of the forearm or humerus (Germany only).
- Active or incompletely treated infections that could involve the site where the device will be implanted.
- Distant foci of infections that may spread to the implant site
- Uncooperative patients or patients, who are incapable of following directions (for example as a consequence of a neurological or psychiatric disorder).
- Concomitant metabolic disorders that may impair bone formation.
- Osteomalacia.
- Allergic to implant materials or dental glue.
- Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
- Polytrauma patients (multiple injuries resulting from a high-impact event, eg- a motor vehicle accident).
- Life expectancy less than one year due to concurrent illness.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany3 sites
St. Vinzenz-Hospital GmbH
Cologne, D-50733
Klinikum Oberberg GmbH
Gummersbach, 51643
Lahn-Dill Kliniken
Wetzlar, 35578
Netherlands3 sites
Amphia Hospital
Breda, 4818 CK
Albert Schweitzer Hospital
Dordrecht, 3318 AT
University Hospital Maastricht
Maastricht, 6229 HX
About this study
Official title: CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures
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.
- Conditions
- Acute Humerus Fractures
- Being tested
- Photodynamic Bone Stabilization System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic Bone Stabilization SystemDevice
Treatment of acute humerus fractures
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Experimental | 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. Receives: Device: Photodynamic Bone Stabilization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal Radiographic Fracture Healing
Two of four cortices or two of four views demonstrating bridging on standard radiographs
Measured: 180 days
Secondary outcomes (9)
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
Measured: 180 and 360 days
Evaluation of Normal Radiographic Healing
Two of four cortices or two of four views demonstrating bridging on standard radiographs
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 180 and 360 days
Summary of Pain on Palpation
Pain at Palpation (yes/no), grade and clinical significance. Grade: mild, moderate, severe
Measured: 180 and 360 days
Summary of Return to Pre-Fracture Mobility
Summary of subjects who returned to pre-fracture mobility (yes/no)
Measured: 180 and 360 days
Summary of Range of Motion
Summary of range of motion (active and passive) for affected and unaffected arm, for abduction, flexion, extension and lateral and medial rotation.
Measured: 180 and 360 days
Summary of Disability Status
Disability status as determined by the investigator
Measured: 180 and 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Humerus FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlluminOss Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394080
- Sponsor's protocol ID
- 12-03-EUHUM-01
- Status last verified
- May 2026
- First submitted
- 16 Mar 2015
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures
- ClinicalTrials.gov ID
- NCT02394080
- Acronym / sponsor ID
- 12-03-EUHUM-01
- Conditions
- Acute Humerus Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- IlluminOss Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Experimental | Device: Photodynamic Bone Stabilization SystemThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic Bone Stabilization SystemTreatment of acute humerus fractures | Device | Photodynamic Bone Stabilization System (PBSS) |
Primary outcome
Normal Radiographic Fracture Healing
Time frame: 180 days
Two of four cortices or two of four views demonstrating bridging on standard radiographs
9 secondary outcomes
Evaluation of Complete Radiographic Healing
Time frame: 180 and 360 days
Evaluation of Normal Radiographic Healing
Time frame: 360 days
Summary of Pain VAS
Time frame: 180 and 360 days
Summary of DASH Score
Time frame: 180 and 360 days
Summary of Constant Shoulder Score
Time frame: 180 and 360 days
Summary of Pain on Palpation
Time frame: 180 and 360 days
Summary of Return to Pre-Fracture Mobility
Time frame: 180 and 360 days
Summary of Range of Motion
Time frame: 180 and 360 days
Summary of Disability Status
Time frame: 180 and 360 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic Bone Stabilization System in people with Acute Humerus Fractures, run by IlluminOss Medical, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal Radiographic Fracture Healing (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.