Recruiting

IlluminOss

Sponsor:

Massachusetts General Hospital

Code:

NCT04842266

Conditions

Cancer Metastatic

Trauma

Pathologic Fracture

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

IlluminOss pelvic implant for oncologic indication

IlluminOss pelvic implant for geriatric trauma indication

Study Details

Brief summary:

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.

Conditions

Cancer Metastatic

Trauma

Pathologic Fracture

Study ID

NCT04842266

Start date

Nov 18, 2021

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Impending or actual non-displaced or minimally displaced pathologic fractures of the pelvis

Patients are being targeted because they have already agreed to the undergo the IlluminOss Pelvic Implant for standard clinical care. Patient-reported outcome surveys will be administered pre-operatively, as well as at 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery.

Pelvic fragility fracture in a geriatric patients (age 65 or older)

Patients are being targeted because they have already agreed to the undergo the IlluminOss Pelvic Implant for standard clinical care. Patient-reported outcome surveys will be administered pre-operatively, as well as at 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery.

Interventions

IlluminOss pelvic implant for oncologic indication

Impending or actual non-displaced or minimally displaced pathologic fractures of the pelvis

IlluminOss pelvic implant for geriatric trauma indication

Pelvic fragility fracture in a geriatric patients (age 65 or older)

Primary outcome measure

  • Survey of patient-reported outcomes [ Time Frame: Pre-operatively through 2 years after surgery ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Kevin A Raskin, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-01-16.