IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pelvis Fractures
Recruiting now
Conditions studied: Cancer Metastatic, Trauma, Pathologic Fracture
In brief
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.
Key facts
- Study ID
- NCT04842266
- Run by
- Massachusetts General Hospital
- People needed
- 100
- Starts
- 2021-11-18
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-01-16
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Patient is a skeletally mature patient 21 years of age or older (closed epiphyseal plates) who receiving the FDA-approved IlluminOss Pelvic Implant
- 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)
- VAS Pain Score ≥ 30 on 0 to 100 scale
You may not qualify if…
- Patient is uncooperative, or patient incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder)
- Patient is a prisoner
- Patient is deemed surgically unfit by the medical oncology service
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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