IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pelvis Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Skeletally mature patients with undergoing surgery 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
IlluminOss pelvic implant for oncologic indication
DeviceImpending or actual non-displaced or minimally displaced pathologic fractures of the pelvis
IlluminOss pelvic implant for geriatric trauma indication
DevicePelvic fragility fracture in a geriatric patients (age 65 or older)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Impending or actual non-displaced or minimally displaced pathologic fractures of the pelvis1 intervention
Group B: Pelvic fragility fracture in a geriatric patients (age 65 or older)1 intervention
Trial outcomes
Primary outcomes
1
Survey of patient-reported outcomes
Patients treated with the IlluminOss pelvic implant will be given functional and pain surveys pre-operatively (within 2 weeks before surgery) and post-operatively (at 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years). 100 patients will be included in the study. The surveys include the VAS Pain, the EQ-VAS, the Combined Pain and Ambulatory Function, the PROMIS Pain Inteference, and the PROMIS Physical Function. Additionally, the MSTS survey will be collected for oncologic patients. If needed, the surveys will be mailed to the patient with a pre-stamped and pre-addressed envelope. When mailing patients MSTS surveys, we will include a set of instructions to guide participants through the questions.
Time frame
Pre-operatively through 2 years after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
IlluminOss Medical, Inc.
Collaborator
University of Miami
Collaborator
Source ClinicalTrials.gov