bone healing Upperarm fracture
Conditions
Interventions
Sponsors
IlluminOss Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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. 2. Fracture is closed, Gustilo Type I or II.;General Inclusion Criteria 3. Skeletally mature men and women, 50 years of age or older at time of index injury. 4. a. Female patients of child bearing potential agree to use double barrier method of contraception b. Female patients of non-child bearing potential must meet one of the following criteria: - Postmenopausal for at least 1 year, or - Documented oophorectomy or hysterectomy, or - Surgically sterile 5. Willing and able understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: Fracture-Specific Exclusion Criteria 1. Index treatment is greater than 28 days 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 7.Active or incompletely treated infections that could involve the site where the device will be implanted. 8. Distant foci of infections that may spread to the implant site. 9. Uncooperative patients or patients who are incapable of following directions (for example as a consequence of a neurological or psychiatric disorder). 10.Concomitant metabolic disorders that may impair bone formation. 11.Osteomalacia. 12.Allergic to implant materials or dental glue. 13.Vascular insufficiency, muscular atrophy, or neuro-muscular disease. 14.Polytrauma patients (multiple injuries resulting from a high impact event, eg- a motor vehicle accident). 15.Life expectancy less than one year due to concurrent illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the assessment of normal radiographic fracture healing; determined at the Day 180 visit. Normal radiographic healing is defined by two of four cortices or two of four views demonstrating bridging on standard radiographs. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints, evaluated at Day 180 and Day 360, include: 1. Assessment of the incidence of adverse events. 2. Assessment of the procedure- and device-related complication rate. The performance secondary endpoints include: 1. Evaluation of complete radiographic healing at Day 180, defined as three of four cortices or three of four views demonstrating bridging, with dissolution of the majority (> 75% on orthogonal views) of fracture lines. 2. Evaluation of normal radiographic healing at Day 360. 3. Evaluation of complete radiographic healing at Day 360, defined as three of four cortices or three of four views demonstrating bridging, with dissolution of the majority (> 75% on orthogonal views) of fracture lines. 4. Assessment of no pain at palpation status. 5. Assessment of return to pre-fracture mobility status. 6. Comparison of pain visual analog score (VAS) from baseline to all follow up intervals. 7. Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals. 8. Comparison of Constant shoulder score from baseline to all follow up intervals. 9. Assessment of range of motion. 10. Assessment of disability status. 11. Assessment of return to work status. In addition to disability and return to work status, the following health economic data may be analyzed: a) Duration of physical therapy prescription. b) The use of supportive orthopedic devices post-surgery. c) The use of prescription and over-the-counter analgesic medication | — |
Countries
Netherlands
Outcome results
None listed