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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 8, 2021

Keywords

ClinConnect Summary

The clinical trial is studying the effectiveness of a special implant called the IlluminOss Pelvic Implant, which is designed to help patients with certain types of pelvic fractures. These fractures can occur due to cancer spreading to the bones, trauma, or weakened bones in older adults. The main goal of the study is to see if using this implant can reduce pain and improve daily function for patients who have either severe pain or are at risk of breaking their pelvis.

To be eligible for this trial, participants need to be at least 21 years old and have already agreed to receive the IlluminOss implant as part of their standard medical care. They should also have a specific level of pain, rated at 30 or higher on a scale from 0 to 100. Patients who are not able to follow instructions or have severe health issues that prevent surgery are not eligible. If you join the trial, you can expect to receive the implant and be monitored for changes in pain and function, contributing important information that could help improve treatment for others in the future.

Gender

ALL

Eligibility criteria

• 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