CE Marking Study of the IlluminOss® Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures - PBSS

IlluminOss Medical, Inc.0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

Trial is onging in other countries

•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.

•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.

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