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Cancer MetastaticNCT04842266

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

An observational study of Cancer Metastatic and Trauma, run by Massachusetts General Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Cancer Metastatic, Trauma, Pathologic Fracture
What is being tested?
IlluminOss pelvic implant for oncologic indication and IlluminOss pelvic implant for geriatric trauma indication
Type of treatment
Medical device
How many people
100 participants
Where
1 siteUnited States
Study dates
18 Nov 2021to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kevin Raskin, MD contact

617-724-3700

kraskin@mgh.harvard.edu

Shreya Halur, BS contact

617-726-4932

shalur@mgh.harvard.edu

United States1 site, 1 recruiting
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Kevin A Raskin, MD, 617-724-3700, kraskin@mgh.harvard.edu

    Shreya Halur, BS, 617-726-4932, shalur@mgh.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: A Prospective Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pathological Fractures in the Pelvis From Metastatic Bone Disease or Geriatric Pelvic Fractures

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.

Read the detailed description

The matrix morphology of the tumors in metastatic bone disease (MBD) may be of blastic, lytic, or mixed characteristics. Cancers of purely lytic or mixed blastic-lytic composition are the most concerning, as they result in local destruction of the cortical and trabecular bone, causing significant pain and increasing the risk of a pathologic fracture. Function and mobility are severely affected in this patient population due to mechanical and oncogenic pain.

Prophylactic fixation of impending pathological fractures from MBD has demonstrated significant clinical benefit in terms of reducing mechanical pain and in decreasing the progression to complete pathologic fracture as well as minimizing the symptoms when these occur. In the later clinical scenario, the degree of fracture displacement, pain and functional limitation in most cases is minimal as the fracture is an already treated condition. In terms of surgical impact to the patient, prophylactic fixation is a faster procedure with lower blood loss rates. Other benefits include, shorter length of hospitalization and higher likelihood of discharge to home, in addition to reduction of pain, improvement in activities of daily living, and better quality of life.

Importantly, efforts have been made to predict fracture risk and the need for prophylactic fixation based upon the clinical and radiographic features of MBD. This is well stablished in long bones of the extremities but it is not as clear or conclusive in the pelvis.

Traditionally, Intramedullary devices are used for the purposes of prophylactic fixation and for treatment of pathologic fractures. Advantages include protection of the whole bone and ability to early bear weight given the biomechanical characteristics as a load sharing device. More commonly, these implants are made of titanium or other metal alloys. In recent years, the development of radiolucent implants has been important in orthopaedic oncology as these facilitate evaluation of bone involvement and radiation therapy planning. One of these radiolucent devices is IlluminOss PBSS. This UV light activated polymer has proved to be effective and safe in the treatment of impending pathologic fractures of the humerus. This intramedullary implant is inserted through small incisions and proved to be as effective as traditional intramedullary nails in relieving pain and returning patients faster to their pre-impending fracture level of activity. This product has been cleared by the FDA for use in the humerus, radius and ulna, clavicle, pelvis, fibula, metacarpals, metatarsals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation in these anatomic sites. The IlluminOss System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.

Pelvic fractures in the elderly are a growing concern as the population ages. While oftentimes treated non-operatively, some require surgical fixation. In addition to the stress which surgery especially puts on geriatric patients, a return to pre-injury mobility is also an important impact and a concern of such procedures.

Contrary to the extremities, there are minimal options for small incision pelvic implants to treat patients suffering from pain or fracture. The complex anatomy of the pelvis does not allow the use of rigid and precontoured implants. Fixation with screws is also challenging given the complex anatomy and high prevalence of vital neurovascular structures in the pelvis.

The non-rigid nature of this polymer in the IlluminOss PBSS makes it suitable to adapt to the complex anatomy of the pelvis. In addition, there is no need to use screws for additional fixation, which is ideal in the pelvis. This implant may allow surgeons to forego the use of screws for fixation because the implant has a 3D anti-rotational profile which generates intrinsic stability when in contact with the inner bone. However, if the surgeon considers that stability is not sufficient, screws may still be used in this study at the surgeon's discretion.

This device has been approved to be used in the pelvis after the experience in a previous study examining its effectiveness in the humerus, radius, and ulna. The purpose of this study is to collect information to effectively measure the improvement in pain control through functional scores after the surgery. We wish to see short term results (2 years) and to have a better understanding of the complication profile.

Being tested
IlluminOss pelvic implant for oncologic indication, IlluminOss pelvic implant for geriatric trauma indication
Medical subject headings
Neoplasm Metastasis, Wounds and Injuries, Fractures, Spontaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IlluminOss pelvic implant for oncologic indicationDevice

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

  • IlluminOss pelvic implant for geriatric trauma indicationDevice

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

Study groups in NCT04842266
Study groupRoleWhat they receive
Impending or actual non-displaced or minimally displaced pathologic fractures of the pelvisPatients 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.
Receives: 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.
Receives: Device: IlluminOss pelvic implant for geriatric trauma indication

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pre-operatively through 2 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2021
  2. Study start18 Nov 2021
  3. Primary completionNov 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04842266
Sponsor's protocol ID
2021P000047
Status last verified
Jan 2026
First submitted
8 Apr 2021
Last updated
16 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 28286623
  • 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.

    PubMed 31635518
  • 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.

    PubMed 31950234
  • 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.

    PubMed 25540600
  • 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.

    PubMed 25783693
  • 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.

    PubMed 27233355
  • 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.

    PubMed 27987018

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer Metastatic and Trauma, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kevin Raskin, MD (617-724-3700, kraskin@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survey of patient-reported outcomes (time frame: Pre-operatively through 2 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04842266, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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