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Trial record 2 of 6 for:    illuminoss

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04842266
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : September 29, 2022
Sponsor:
Collaborator:
IlluminOss Medical, Inc.
Information provided by (Responsible Party):
Santiago Lozano-Calderon, Massachusetts General Hospital

Tracking Information
First Submitted Date April 8, 2021
First Posted Date April 13, 2021
Last Update Posted Date September 29, 2022
Actual Study Start Date November 18, 2021
Estimated Primary Completion Date October 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2021)
  • VAS pain improvement [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 8, 2021)
  • PROMIS Physical Function improvement [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pelvis Fractures
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
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Skeletally mature patients with impending or actual pathological fracture secondary to metastatic bone disease OR geriatric patients with fragility fractures of the pelvis who are being targeted because they have already agreed to the undergo the IlluminOss pelvic implant for standard clinical care
Condition
  • Cancer Metastatic
  • Trauma
  • Pathologic Fracture
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • 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
    Intervention: Device: IlluminOss Pelvic Implant for the Treatment of Impending and Actual Pathological Fractures in the Pelvis from Metastatic Bone Disease
  • 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
    Intervention: Device: IlluminOss Pelvic Implant for the Treatment of Geriatric Pelvic Fractures
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 8, 2021)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 15, 2024
Estimated Primary Completion Date October 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • General Inclusion Criteria

    1. Skeletally mature adult males and females (closed epiphyseal plates) 21 years of age or older.
    2. 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:

      1. acetabulum as less than 2mm
      2. iliac bone as less than 1cm
      3. ischium as less than 1cm
      4. sacrum as less than 2mm
      5. pubic bone as less than 2cm
    3. 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
    4. Patient, or his/her legally authorized representative, is able to understand and provide informed consent.
    5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
    6. VAS Pain Score ≥ 30mm on 100mm scale

      OR

    1. Geriatric patients (aged 65 or older)
    2. 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:

  1. acetabulum as less than 2mm
  2. ischium as less than 1cm
  3. sacrum as less than 2mm
  4. pubic bone as less than 2cm

    3. Patient, or his/her legally authorized representative, is able to understand and provide informed consent.

    4. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.

    5. Fracture is closed

    Impending Fracture-Specific Inclusion Criteria

    7. Documented presence of at least one metastatic lesion of the pelvis.

    8. 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).

    9. 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

    1. Primary tumor (osteogenic origin, etc.) at site.
    2. 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
    3. Active or incompletely treated infections that could involve the device implant site.
    4. Distant foci of infection that may spread to the implant site.
    5. Allergy to implant materials or dental glue.
    6. 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).
    7. In the Investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders.
    8. Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).
    9. Prisoner.
    10. Life expectancy less than three months.
    11. Any intra-articular displacement larger than 3 mm in the fracture site.
    12. Open fractures
    13. Patients whose intramedullary region at site of fracture measures smaller than the diameter of the sheath provided.

    Impending Fracture-Specific Exclusion Criteria

    10. 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.

    11. Destruction of cortical bone at impending fracture site < 50%.

    12. Any intra-articular displacement larger than 3 mm in the fracture site.

    Actual Fracture-Specific Exclusion Criteria

    14. Open fractures with severe contamination.

    15. Patients whose intramedullary region at site of fracture or impending fracture that measures smaller than the diameter of the sheath provided.

Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Emily A Berner, BS 6176433513 eaberner@mgh.harvard.edu
Contact: Santiago A Lozano-Calderon, MD, PhD 617-643-4947
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04842266
Other Study ID Numbers 2021P000047
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement Not Provided
Current Responsible Party Santiago Lozano-Calderon, Massachusetts General Hospital
Original Responsible Party Same as current
Current Study Sponsor Massachusetts General Hospital
Original Study Sponsor Same as current
Collaborators IlluminOss Medical, Inc.
Investigators Not Provided
PRS Account Massachusetts General Hospital
Verification Date September 2022