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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04835428




Registration number
NCT04835428
Ethics application status
Date submitted
5/04/2021
Date registered
8/04/2021

Titles & IDs
Public title
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients with Vertebral Compression Fractures
Scientific title
A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment
Secondary ID [1] 0 0
STAND
Secondary ID [2] 0 0
AGN-CIP-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vertebral Compression Fracture 0 0
Compression Fracture 0 0
Vertebral Compression 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Treatment Group: AGN1 LOEP SV Kit
Treatment: Devices - Control Group: PMMA bone cement

Experimental: Treatment with AGN1 LOEP SV Kit - The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone.

Active comparator: Treatment with PMMA bone cement - High viscosity PMMA bone cement will be used for vertebral augmentation.


Treatment: Devices: Treatment Group: AGN1 LOEP SV Kit
The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone.

Treatment: Devices: Control Group: PMMA bone cement
High viscosity PMMA bone cement will be used for vertebral augmentation.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Change in function
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Radiographic evidence of implant resorption (Intervention Group only)
Timepoint [3] 0 0
24 months
Primary outcome [4] 0 0
Radiographic evidence of bone formation (Intervention Group only)
Timepoint [4] 0 0
24 months
Primary outcome [5] 0 0
Adverse events
Timepoint [5] 0 0
24 months

Eligibility
Key inclusion criteria
1. Subject is a male or female 50 years of age or older at the time of study treatment.
2. Subject has one (1) or two (2) acute VCF(s). Note that subjects are eligible if they have an asymptomatic, healed VCF(s) at any non-target vertebral level.
3. Each target VCF meets all of the following criteria:

1. Due to diagnosed or presumed underlying osteoporosis
2. T1 to L5 inclusively
3. Target VCF-related pain = 6 months at time of study treatment
4. Each target VCF shows loss of height of the vertebral body = 50% based on X-ray at baseline.
5. Each target VCF is acute or persistent (not healed), as demonstrated on imaging, including T2-weighted, STIR MRI, bone scan or bone scan with SPECT/CT, serial radiographs, or other serial imaging demonstrating acuity.
6. Focal tenderness to palpation of the spinal process of each target VCF on the physical exam correlates with imaging.
7. Subject has failed conservative medical therapy (bed rest, observation, chiropractic care, orthotics, opioid and non-opioid analgesics, and/or physical therapy), defined as either having a VAS back pain score of = 70 mm after 24 hours to 6 weeks of conservative care or a VAS back pain score of = 50 mm after more than 6 weeks of conservative care.
8. Subject has an Oswestry Disability Index (ODI) score of = 30% at baseline.
9. Subject is capable of giving written informed consent to participate in the study.
10. The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full length of the study has been documented
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. At least one of the target VCF(s) is unstable, including split or burst fracture.
2. Subject has a bleeding disorder.
3. Subject has an active infection of the spine or surgical site.
4. Subject has a bloodborne infection.
5. At least one of the target VCFs is due to underlying or suspected tumor.
6. At least one of the target VCFs is due to high-energy trauma.
7. At least one of the target VCFs is due to osteonecrosis.
8. At least one of the target VCFs has a local kyphotic angle of > 30 degrees, measured as the angle between the superior endplate and inferior endplate at the target VCF.
9. Subject has had any prior surgical treatment at the target vertebral level or adjacent vertebral levels.
10. The pedicle(s) in the target vertebral body appears unable to safely accommodate transpedicular access instrumentation.
11. Subject has neurologic symptoms, deficits, or radiculopathy related to the target VCF(s).
12. Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
13. Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus or spinal stenosis.
14. Subject has spondylolisthesis > Grade 1 at target vertebral body(ies).
15. Subject requires daily opioid medication for pain not related to the target VCF(s).
16. Subject has severe cardiopulmonary deficiencies.
17. Subject has a Body Mass Index (BMI) > 35.
18. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
19. Subject has a history of tuberculous spondylitis.
20. Subject has a history of invasive malignancy within the last five (5) years, other than non-melanoma skin cancer. Subject is not excluded if they have a history of malignancy over 5 years ago treated with curative intent and without clinical signs or symptoms since then.
21. Subject is on oral or parenteral immune-suppressive drugs.
22. Subject has uncontrolled diabetes mellitus.
23. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min.
24. Subject has a diagnosed calcium metabolism disorder.
25. Subject has known allergies to calcium-based bone void fillers.
26. Subject is pregnant or planning to become pregnant during participation in the study.
27. In the judgment of the Investigator, the subject is not a good study candidate. (e.g. substance abuse or chemical dependency, inability to adhere to follow-up schedule, progression of the fracture between screening and the procedure visit).
28. Subject is currently enrolled in another interventional clinical study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
408
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AgNovos Healthcare, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kern Singh
Address 0 0
Midwest Orthopedics at Rush
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Allison Gorman
Address 0 0
Country 0 0
Phone 0 0
2407536424
Fax 0 0
Email 0 0
agorman@agnovos.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04835428