Using IlluminOss implants to treat pelvic fractures in cancer patients
A Prospective Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pathological Fractures in the Pelvis From Metastatic Bone Disease or Geriatric Pelvic Fractures
This study is testing if IlluminOss implants can help cancer patients with pelvic fractures feel less pain and improve their daily activities.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04842266 on ClinicalTrials.gov |
What this trial studies
This project evaluates the effectiveness of the IlluminOss pelvic implants in patients suffering from pelvic metastatic disease, focusing on those with pain and risk of pathologic fractures. The study aims to confirm significant reductions in pain and improvements in function for patients with non-displaced or minimally displaced fractures, as well as geriatric patients with pelvic fragility fractures. By utilizing prophylactic fixation, the study seeks to minimize symptoms and enhance quality of life for this vulnerable population. The research will analyze clinical and radiographic features to better predict fracture risk and the need for intervention.
Who should consider this trial
Good fit: Ideal candidates include skeletally mature patients aged 21 and older with impending or actual non-displaced pelvic fractures due to metastatic malignancy or geriatric patients aged 65 and older with pelvic fragility fractures.
Not a fit: Patients who are uncooperative, incapable of following directions, prisoners, or deemed surgically unfit will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve mobility for patients with pelvic fractures due to metastatic cancer.
How similar studies have performed: Previous studies have shown success with prophylactic fixation in long bones, but this approach in the pelvis is less established and may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Kevin Raskin, MD
- Email: kraskin@mgh.harvard.edu
- Phone: 617-724-3700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.