RecruitingNot Applicable

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

United States100 participantsStarted 2021-11-18

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Survey of patient-reported outcomes

Timeframe: Pre-operatively through 2 years after surgery

Trial details

NCT IDNCT04842266

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-11

Contact for this trial

Kevin Raskin, MD

617-724-3700 kraskin@mgh.harvard.edu

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