Acute Humerus Fractures
Conditions
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.
Interventions
Treatment of acute humerus fractures
Sponsors
IlluminOss Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normal Radiographic Fracture Healing | 180 days | Two of four cortices or two of four views demonstrating bridging on standard radiographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Evaluation of Normal Radiographic Healing | 360 days | Two of four cortices or two of four views demonstrating bridging on standard radiographs |
| Summary of Pain VAS | 180 and 360 days | 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) |
| Summary of DASH Score | 180 and 360 days | 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) |
| Summary of Constant Shoulder Score | 180 and 360 days | 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). |
| Summary of Pain on Palpation | 180 and 360 days | Pain at Palpation (yes/no), grade and clinical significance. Grade: mild, moderate, severe |
| Summary of Return to Pre-Fracture Mobility | 180 and 360 days | Summary of subjects who returned to pre-fracture mobility (yes/no) |
| Summary of Range of Motion | 180 and 360 days | Summary of range of motion (active and passive) for affected and unaffected arm, for abduction, flexion, extension and lateral and medial rotation. |
| Summary of Disability Status | 180 and 360 days | Disability status as determined by the investigator |
Countries
Germany, Netherlands
Participant flow
Recruitment details
44 patients signed the informed consent form. 44 is the modified intent to treat group, 33 is the intent to treat group
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 76.6 years STANDARD_DEVIATION 10.16 |
| AO Classification 02-A3 | 0 Participants |
| AO Classification 11-A1 | 1 Participants |
| AO Classification 11-A2 | 8 Participants |
| AO Classification 11-A3 | 2 Participants |
| AO Classification 11-B1 | 9 Participants |
| AO Classification 11-B2 | 13 Participants |
| AO Classification 11-C2 | 0 Participants |
| Gustilo Grading of Soft Tissue Closed | 26 Participants |
| Gustilo Grading of Soft Tissue Type I | 7 Participants |
| Location Diaphyseal | 1 Participants |
| Location Distal | 0 Participants |
| Location Proximal | 32 Participants |
| Location of Target Fracture Left Humerus | 23 Participants |
| Location of Target Fracture Right Humerus | 10 Participants |
| Neer's Fracture Grading 2-part | 11 Participants |
| Neer's Fracture Grading 3-part | 14 Participants |
| Neer's Fracture Grading 4-part | 4 Participants |
| Neer's Fracture Grading N/A | 4 Participants |
| Region of Enrollment Germany | 11 Participants |
| Region of Enrollment Netherlands | 22 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 8 Participants |
| Traumatic Injury Specify Other | 10 Participants |
| Traumatic Injury Specify Sports Injury | 2 Participants |
| Type of Injury Non-Traumatic | 1 Participants |
| Type of Injury Non-Traumatic, low energy fall | 20 Participants |
| Type of Injury Traumatic | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 33 |
| other Total, other adverse events | 14 / 33 |
| serious Total, serious adverse events | 14 / 33 |
Outcome results
None listed