IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pelvis Fractures
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Treatment of Impending and Actual Pathologic Fractures in the Pelvis from Metastatic Bone Disease The patient will undergo surgery and will be treated with the IlluminOss implant. Patients will be evaluated and given questionnaires post operatively at 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months |
Device: IlluminOss Pelvic Implant for the Treatment of Impending and Actual Pathological Fractures in the Pelvis from Metastatic Bone Disease
The study design is prospective and single center with the purpose of evaluating the performance of the IlluminOss Pelvic Implant in the treatment of pain due to impending or actual non-displaced or minimally displaced pathologic fractures of the pelvis secondary to metastatic malignancy in skeletally mature adults.
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| Treatment of Geriatric Pelvic Fractures with IlluminOss Pelvic Implant Geriatric pelvic fracture patients will be treated with the IlluminOss Pelvic Implant. Patients will be evaluated and given questionnaires post operatively at 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months |
Device: IlluminOss Pelvic Implant for the Treatment of Geriatric Pelvic Fractures
The study design is prospective and single center with the purpose of evaluating the performance of the IlluminOss Pelvic Implant in the treatment of pain due to geriatric pelvic fractures.
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Outcome Measures
Primary Outcome Measures
- VAS pain improvement [Day 90]
The primary endpoint is change in VAS from baseline to Day 90. All patients will be included in the primary analysis of this endpoint through the use of a mixed model repeated measures (MMRM) model assuming an unstructured covariance matrix. To be conservative, statistical power is evaluated on the basis of a single-sample t-test with a 1-sided alpha=0.05 based on the change at Day 90.
- PROMIS Pain improvement [Day 90]
The secondary endpoint is change in PROMIS Pain from baseline to Day 90. All patients will be included in the primary analysis of this endpoint through the use of a mixed model repeated measures (MMRM) model assuming an unstructured covariance matrix. To be conservative, statistical power is evaluated on the basis of a single-sample t-test with a 1-sided alpha=0.05 based on the change at Day 90.
Secondary Outcome Measures
- PROMIS Physical Function improvement [Day 90]
The secondary endpoint is change in PROMIS Physical Function from baseline to Day 90. All patients will be included in the primary analysis of this endpoint through the use of a mixed model repeated measures (MMRM) model assuming an unstructured covariance matrix. To be conservative, statistical power is evaluated on the basis of a single-sample t-test with a 1-sided alpha=0.05 based on the change at Day 90.
- MSTS improvement [Day 90]
The second primary endpoint, to be tested if the above null hypothesis for improvement in VAS is rejected, is change in MSTS from baseline at Day 90; this will be analyzed a similar MMRM manner as the primary endpoint above. This will only be for the oncologic group.
Eligibility Criteria
Criteria
Inclusion Criteria:
- General Inclusion Criteria
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Skeletally mature adult males and females (closed epiphyseal plates) 21 years of age or older.
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Impending or actual non-displaced or minimally displaced pathological fracture of the pelvis, secondary to metastatic bone disease. Fractures will be classified by region (acetabulum, ilium, ischium, sacrum, and pubis). According to the region, different criteria for inclusion will be applied.
Displacement will be classified in the:
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acetabulum as less than 2mm
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iliac bone as less than 1cm
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ischium as less than 1cm
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sacrum as less than 2mm
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pubic bone as less than 2cm
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Females: neither pregnant nor intending to become pregnant during the course of the study will be enrolled in the study. Women defined as follows will be eligible for enrollment: a. Postmenopausal for at least 1 year OR b. Documented oophorectomy or hysterectomy c. Surgically sterile d. If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
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Patient, or his/her legally authorized representative, is able to understand and provide informed consent.
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Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
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VAS Pain Score ≥ 30mm on 100mm scale
OR
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Geriatric patients (aged 65 or older)
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Fragility fractures of the pelvis, specifically a pathologic fracture, or osteoporotic fracture that results from minimal trauma (i.e. fall from standing height)
Fractures will be classified and marked as eligible by displacement in a particular region (acetabulum, ilium, ischium, sacrum, and pubis). According to the region, different criteria for inclusion will be applied.
Displacement will be classified in the:
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acetabulum as less than 2mm
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ischium as less than 1cm
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sacrum as less than 2mm
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pubic bone as less than 2cm
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Patient, or his/her legally authorized representative, is able to understand and provide informed consent.
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Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
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Fracture is closed
Impending Fracture-Specific Inclusion Criteria
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Documented presence of at least one metastatic lesion of the pelvis.
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Lytic or mixed matrix lesion, measuring at least 3 cm in size in an area at risk of pathologic fracture and causing mechanical pain with axial loading of the affected site. (There is no Mirels for pelvis).
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Non-displaced or minimally displaced pathologic fractures of the pubic bone, iliac bone, acetabulum and/or ischium, causing mechanical pain on axial loading of the affected site.
Actual Fracture-Specific Inclusion Criteria 10. Fracture is closed, Gustilo Type I or II open fractures
Exclusion Criteria:
- General Exclusion Criteria
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Primary tumor (osteogenic origin, etc.) at site.
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Impending or actual fracture at any other location, that in the Investigator's opinion, would preclude ability to assess pain and/or function in the target pelvis
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Active or incompletely treated infections that could involve the device implant site.
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Distant foci of infection that may spread to the implant site.
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Allergy to implant materials or dental glue.
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In the Investigator's judgment, functional deficit in the target pelvis with an etiology other than bone metastases (e.g. due to avascular bone necrosis).
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In the Investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders.
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Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).
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Prisoner.
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Life expectancy less than three months.
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Any intra-articular displacement larger than 3 mm in the fracture site.
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Open fractures
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Patients whose intramedullary region at site of fracture measures smaller than the diameter of the sheath provided.
Impending Fracture-Specific Exclusion Criteria
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Lytic or mixed matrix lesion, measuring at less than 3 cm in size or less than 30 cm in an area at risk of pathologic fracture and causing mechanical pain with axial loading of the affected site.
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Destruction of cortical bone at impending fracture site < 50%.
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Any intra-articular displacement larger than 3 mm in the fracture site.
Actual Fracture-Specific Exclusion Criteria
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Open fractures with severe contamination.
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Patients whose intramedullary region at site of fracture or impending fracture that measures smaller than the diameter of the sheath provided.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- IlluminOss Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Gausepohl T, Pennig D, Heck S, Gick S, Vegt PA, Block JE. Effective Management of Bone Fractures with the Illuminoss® 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.
- 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® System (IO-Wrist); a multicenter prospective observational study. BMC Musculoskelet Disord. 2016 May 27;17:235. doi: 10.1186/s12891-016-1077-9.
- Stumpf M, Kraus T, Plötz 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.
- Surke C, Meier R, Haug L, Vögelin 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.
- 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(®) System. Eur J Trauma Emerg Surg. 2021 Aug;47(4):1129-1136. doi: 10.1007/s00068-019-01289-w. Epub 2020 Jan 16.
- 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.
- Zyskowski M, Crönlein 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.
- 2021P000047