IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pelvis Fractures

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04842266
Status
Recruiting
Apply to this trial

Conditions

  • Cancer Metastatic
  • Pathologic Fracture
  • Trauma

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IlluminOss pelvic implant for oncologic indication — DEVICE
    Impending or actual non-displaced or minimally displaced pathologic fractures of the pelvis
  • IlluminOss pelvic implant for geriatric trauma indication — DEVICE
    Pelvic fragility fracture in a geriatric patients (age 65 or older)

Study Details

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 Dates

Start date
Nov 18, 2021
Status verified
Jan 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Kevin A Raskin, MD
[email protected]
617-724-3700
Shreya Halur, BS
[email protected]
617-726-4932
Kevin A Raskin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies