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

NCT04842266 | Recruiting FDA Device

• 1 other identifier: 2021P000047
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Pre-operatively through 2 years after surgery

Study Arms (2)

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.

Device: IlluminOss pelvic implant for oncologic indication

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.

Device: IlluminOss pelvic implant for geriatric trauma indication

Interventions

IlluminOss pelvic implant for oncologic indication DEVICE

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

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)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You 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 may not qualify 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• IlluminOss Medical, Inc.: collaborator
• University of Miami: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (7)

• Gausepohl T, Pennig D, Heck S, Gick S, Vegt PA, Block JE. Effective Management of Bone Fractures with the Illuminoss(R) Photodynamic Bone Stabilization System: Initial Clinical Experience from the European Union Registry. Orthop Rev (Pavia). 2017 Feb 20;9(1):6988. doi: 10.4081/or.2017.6988. eCollection 2017 Feb 20.

  PMID: 28286623 BACKGROUND

• Surke C, Meier R, Haug L, Vogelin E. Osteosynthesis of fifth metacarpal neck fractures with a photodynamic polymer bone stabilization system. J Hand Surg Eur Vol. 2020 Feb;45(2):119-125. doi: 10.1177/1753193419880775. Epub 2019 Oct 22.

  PMID: 31635518 BACKGROUND

• Van Oijen GW, Vegt PA, Hagenaars T, Van Lieshout EMM, Verhofstad MHJ. Outcome after treatment of distal radius fractures in the elderly using the IlluminOss(R) System. Eur J Trauma Emerg Surg. 2021 Aug;47(4):1129-1136. doi: 10.1007/s00068-019-01289-w. Epub 2020 Jan 16.

  PMID: 31950234 BACKGROUND

• Vegt P, Muir JM, Block JE. The Photodynamic Bone Stabilization System: a minimally invasive, percutaneous intramedullary polymeric osteosynthesis for simple and complex long bone fractures. Med Devices (Auckl). 2014 Dec 12;7:453-61. doi: 10.2147/MDER.S71790. eCollection 2014.

  PMID: 25540600 BACKGROUND

• Stumpf M, Kraus T, Plotz W, Jakobs TF. [Stabilization of the pelvic ring with photodynamic bone stabilization (IlluminOss)]. Unfallchirurg. 2015 Mar;118(3):279-82. doi: 10.1007/s00113-015-2743-3. German.

  PMID: 25783693 BACKGROUND

• Hagenaars T, Van Oijen GW, Roerdink WH, Vegt PA, Vroemen JP, Verhofstad MH, Van Lieshout EM. Functional recovery after treatment of extra-articular distal radius fractures in the elderly using the IlluminOss(R) System (IO-Wrist); a multicenter prospective observational study. BMC Musculoskelet Disord. 2016 May 27;17:235. doi: 10.1186/s12891-016-1077-9.

  PMID: 27233355 BACKGROUND

• Zyskowski M, Cronlein M, Heidt E, Biberthaler P, Kirchhoff C. [Osteosynthesis of distal fibular fractures with IlluminOss : Video article]. Unfallchirurg. 2017 Jan;120(1):6-11. doi: 10.1007/s00113-016-0285-y. German.

  PMID: 27987018 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis; Wounds and Injuries; Fractures, Spontaneous

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone

Central Study Contacts

Kevin Raskin, MD

CONTACT

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

Shreya Halur, BS

CONTACT

617-726-4932; shalur@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: November 18, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)