Humerus Pathological Fracture
Conditions
Brief summary
The purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.
Interventions
Treatment of impending and actual pathological fractures of the humerus
Sponsors
IlluminOss Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-General Inclusion Criteria 1. Skeletally mature adult males and females 18 years of age or older. 2. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease. 3. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as: 1. Postmenopausal for at least 1 year OR 2. Documented oophorectomy or hysterectomy 3. Surgically sterile OR 4. 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 4. Able to understand and provide informed consent. 5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule. -Impending Fracture-Specific Inclusion Criteria 6. Documented presence of solitary metastatic lesion. 7. Mirels Criteria Score ≥ 8. 8. Destruction of cortical bone at impending fracture site \> 50%. -Actual Fracture-Specific Inclusion Criteria 9. Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A1, 11A2 and 11B1, 11B2 and 12A1,12A2 and 12B1, 12B2 and 13A1,13A2 and 13B1, 13B2. 10. Fracture is closed, Gustilo Type I or IIA.
Exclusion criteria
-General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | 90 days | VAS Pain Score change of \> -33% compared to baseline. Visual Analog Scale (VAS) pain score is based on a 100 mm line. The subject places a mark on the line to indicate the level of pain. The scale goes from 0 (no pain) to 100 (worst imaginable pain). The distance on the line from zero to the mark indicates the score. |
| Functional Improvement - Barthel Index | 90 days | Barthel Index of Activities of Daily Living (ADLs) improvement of \>= +10% from baseline. Total score ranges from 0 to 100 points (scores on a scale). Higher scores indicate greater independence and better functional outcome, while lower scores indicate greater dependence and worse functional outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | 180 and 360 days | VAS Pain Score change of \>= -33% compared to baseline. Visual Analog Scale (VAS) pain score is based on a 100 mm line. The subject places a mark on the line to indicate the level of pain. The scale goes from 0 (no pain) to 100 (worst imaginable pain). The distance on the line from zero to the mark indicates the score. |
| Summary Percent Change From Baseline of Visual Analog Scale (VAS) Pain Score | 90, 180, 360 days | Visual Analog Scale (VAS) pain score is based on a 100 mm line. The subject places a mark on the line to indicate the level of pain. The scale goes from 0 (no pain) to 100 (worst imaginable pain). The distance on the line from zero to the mark indicates the score. |
| Functional Improvement - Barthel Index | 180 and 360 days | Barthel Index of Activities of Daily Living (ADLs) improvement of \>= +10% from baseline. Total score ranges from 0 to 100 points (scores on a scale). Higher scores indicate greater independence and better functional outcome, while lower scores indicate greater dependence and worse functional outcome. |
| Change From Baseline of Barthel Index of Activities of Daily Living | 90, 180, 360 Days | Change from baseline in Barthel Index of Activities of Daily Living Score by visit. Scores for each scale and domain are transformed to range from 0 to 100 points (scores on a scale). Higher scores indicate better functional status and improved quality of life outcomes, while lower scores indicate worse functioning. |
| Functional Improvement - EORTC QLQ-C30 | 90, 180, 360 days | Functional Improvement using EORTC QLQ-C30 improvement of \>= +10% from baseline. Scores for each scale and domain are transformed to range from 0 to 100 points (scores on a scale). Higher scores indicate better functional status and improved quality of life outcomes, while lower scores indicate worse functioning. |
| Functional Improvement - EORTC QLQ-BM22 | 90, 180, 360 days | Functional Improvement - EORTC QLQ-BM22 \>= 10% change from baseline. Scores for each scale and domain are transformed to range from 0 to 100 points (scores on a scale). Higher scores indicate better functional status and improved quality of life outcomes, while lower scores indicate worse functioning. |
| Surgical Interventions | 90, 180, 360 days | Surgical interventions include revisions, supplements, fixations and removals |
| Device Status | 90, 180, 360 days | Summary of device status (intact and in-place) |
| Serious Device-Related Complications | 90, 180, 360 days | Summary of serious device-related complications |
Countries
Austria, Germany, Netherlands
Participant flow
Pre-assignment details
14 were enrolled but only 9 are in the intent-to-treat population. Analysis presented for the 9
Baseline characteristics
| Characteristic | — |
|---|---|
| Actual Bone Fracture Characteristics - AO Classification 11-A2 | 3 Participants |
| Actual Bone Fracture Characteristics - AO Classification 12-A1 | 1 Participants |
| Actual Bone Fracture Characteristics - AO Classification 12-A2 | 2 Participants |
| Actual Bone Fracture Characteristics - AO Classification 13-A2 | 1 Participants |
| Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue Type I | 4 Participants |
| Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue Type IIA | 1 Participants |
| Actual Bone Fracture Characteristics - Location Diaphyseal | 3 Participants |
| Actual Bone Fracture Characteristics - Location Proximal | 4 Participants |
| Actual Bone Fracture Characteristics - Location of Target Fracture Left Humerus | 4 Participants |
| Actual Bone Fracture Characteristics - Location of Target Fracture Right Humerus | 3 Participants |
| Age, Continuous | 68.6 years STANDARD_DEVIATION 5.85 |
| Fracture Type Actual | 7 Participants |
| Fracture Type Impending | 2 Participants |
| Impending Bone Fracture Characteristics - Location Diaphyseal | 1 Participants |
| Impending Bone Fracture Characteristics - Location Proximal | 1 Participants |
| Impending Bone Fracture Characteristics - Location of Target Fracture Left Humerus | 0 Participants |
| Impending Bone Fracture Characteristics - Location of Target Fracture Right Humerus | 2 Participants |
| Pain (VAS Score) | 58.6 units on a scale STANDARD_DEVIATION 35.09 |
| Region of Enrollment Austria | 3 participants |
| Region of Enrollment Germany | 2 participants |
| Region of Enrollment Netherlands | 4 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 14 |
| other Total, other adverse events | 4 / 14 |
| serious Total, serious adverse events | 10 / 14 |
Outcome results
None listed