IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pelvis Fractures

Summary

The aim of this project is to assess the effectiveness of the IlluminOss pelvic implants in patients with pelvic metastatic disease presenting with pain, risk of pathologic fracture, non-displaced or minimally displaced pathologic fracture of the pelvis, and geriatric patients with pelvic fragility fractures. Results from this study will be used to confirm preliminary clinically and possibly statistically significant reductions in pain and improvements in function among these patients.

Eligibility

Inclusion criteria:

Patients are being targeted because they have already agreed to the undergo the IlluminOss Pelvic Implant for standard clinical care. It is a decision made by the treating surgeon separately from research and prior to mention of the study.

1. Patient is a skeletally mature patient 21 years of age or older (closed epiphyseal plates) who receiving the FDA-approved IlluminOss Pelvic Implant
2. IlluminOss Pelvic Implant is intended to treat pain due to impending or actual non-displaced or minimally displaced pathologic fractures of the pelvis secondary to metastatic malignancy, multiple myeloma, lymphoma, or radiation osteitis or a pelvic fragility fracture in a geriatric patients (age 65 or older)
3. VAS Pain Score ≥ 30 on 0 to 100 scale

Exclusion criteria:

1. Patient is uncooperative, or patient incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder)
2. Patient is a prisoner
3. Patient is deemed surgically unfit by the medical oncology service

Conditions4

Locations1 site

Browse More Trials