bone healing upper arm fracture
Conditions
Interventions
Sponsors
IlluminOss Medical In.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria: - Skeletally mature adult males and females 18 years of age or older - Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease - Females: neither pregnant nor intending to become pregnant during the course of the study - Able to understand and provide informed consent - Willing and able to comply with post-operative treatment protocol and follow-up visit schedule;Impending Fracture-Specific Inclusion Criteria: - Documented presence of solitary metastatic lesion. - Mirels Criteria Score >= 8. - Destruction of cortical bone at impending fracture site > 50%.;Actual Fracture-Specific Inclusion Criteria: - 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. - Fracture is closed, Gustilo Type I or IIA
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: - Primary tumor (osteogenic origin, etc.) at site - Impending fracture or actual fracture location other than humerus - Current concomitant traumatic fracture of any other location - Active or incompletely treated infections that could involve the device implant site - Distant foci of infection that may spread to the implant site - Allergy to implant materials or dental glue - Vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site - Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder);Impending Fracture-Specific Exclusion Criteria: - Mirels Score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters is subject success which is determined by achieving the safety and effectiveness endpoints at the Day 90 Visit. Safety Success is evaluated by meeting all of the following criteria: • Clinical - No Serious Device Related Complications - No additional surgical interventions (i.e.revisions, supplements, fixations, or removals) • Radiographic - No device fracture, migrations, mal-alignment or loss of reduction or fixation Effectiveness Success is evaluated by achieving pain reduction and functional improvement: • Pain Reduction - VAS Pain Score change of >= -33% compared to baseline • Functional Improvement - Barthel Index of Activities of Daily Living (ADLs) improvement of >= +10% from baseline - EORTC QLQ-C30 improvement of > +10% from baseline - EORTC QLQ-BM22 improvement of > +10% from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints, evaluated at the Day 90 Visit, and at the Extended Follow Up Visits include: 1. The seven composite endpoint components listed under the primary endpoint. Other secondary endpoints include: 2. Duration of index procedure and length of hospital stay. 3. Activities of Daily Living score through all follow-up intervals. 4. VAS Pain score from baseline through all follow-up intervals. 5. Disability status. 6. Evaluation of duration of physical therapy prescription. 7. Assessment of prescription and over-the-counter analgesic medication use. 8. Survivability from time of index procedure to death. The safety endpoints evaluated include: 1. Incidence and number of AEs. 2. Incidence and number of procedure- and device-related complications. | — |
Countries
Netherlands
Outcome results
None listed