Overview
Determine whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure
Description
Primary Objectives
- Evaluate whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure
Secondary Objectives
- Evaluate whether the procedure relieves pain
- Evaluate radiographic stability of the implant
- Evaluate functional outcome at earlier time points (2 weeks or 6 weeks) and at 6 months and possibly later time points
- Evaluate reoperation rate and complications
Eligibility
Inclusion Criteria:
- Patients must have histologically confirmed malignancy that is metastatic to the peri-acetabular region of the pelvis. This would include metastatic carcinomas, myeloma, and lymphoma.
- Age ≥18 years (Illuminoss is approved only for skeletally mature patients)
- Suitable candidate for general anesthesia
- Ability to understand and the willingness to sign a written informed consent document.
- Able and willing to fill out pre-operative and post-operative functional outcome surveys
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 50,000/mcL
Exclusion Criteria:
- Patients with uncontrolled intercurrent illness (e.g., recent pneumonia or myocardial infarction that would significantly increase risk of general anesthesia)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because of the risk of general anesthesia and radiation exposure (fluoroscopy) to the fetus
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to dental resins or PET.