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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

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
Cancer Metastatic Trauma Pathologic Fracture Device: IlluminOss Pelvic Implant for the Treatment of Impending and Actual Pathological Fractures in the Pelvis from Metastatic Bone Disease Device: IlluminOss Pelvic Implant for the Treatment of Geriatric Pelvic Fractures

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 18, 2021
Estimated Primary Completion Date : October 15, 2024
Estimated Study Completion Date : October 15, 2024

Resource links provided by the National Library of Medicine


Group/Cohort 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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842266


Contacts
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Contact: Emily A Berner, BS 6176433513 eaberner@mgh.harvard.edu
Contact: Santiago A Lozano-Calderon, MD, PhD 617-643-4947

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Emily A Berner, BS    617-643-3513    eaberner@mgh.harvard.edu   
Contact: Santiago A Lozano-Calderon, MD, PhD    617-643-4947      
Principal Investigator: Santiago A Lozano-Calderon, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
IlluminOss Medical, Inc.
Publications:

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Responsible Party: Santiago Lozano-Calderon, Attending Orthopaedic Surgeon/Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04842266    
Other Study ID Numbers: 2021P000047
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Spontaneous
Wounds and Injuries