What this study is
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.
What's being tested
- IlluminOss pelvic implant for oncologic indication
Intervention · DEVICE
Impending or actual non-displaced or minimally displaced pathologic fractures of the pelvis
- IlluminOss pelvic implant for geriatric trauma indication
Intervention · DEVICE
Pelvic fragility fracture in a geriatric patients (age 65 or older)
Study details
- Official title
- 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
- Sponsor
- Massachusetts General Hospital
- Conditions
- Cancer Metastatic · Trauma · Pathologic Fracture
- Enrolling
- 100 people
- Starts
- 2021-11-18
- Est. completion
- 2027-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Kevin A Raskin, MD · Contact617-724-3700kraskin@mgh.harvard.edu
- Shreya Halur, BS · Contact617-726-4932shalur@mgh.harvard.edu
- Kevin A Raskin, MD · Principal investigator
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2021P000047
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.