Clinical trial NCT04835428: STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vertebral Compression Fracture
Compression Fracture
Vertebral Compression
Keywords: LOEP
AGN1
STAND
Local Osteo-Enhancement Procedure
Lead sponsor: AgNovos Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 408
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four hundred eight (408) eligible subjects at up to twenty-five (25) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group).
Primary purpose: TREATMENT

Brief summary: This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement.

Detailed description: Four hundred and eight (408) eligible subjects at up to twenty-five (25) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group).

1. Intervention Group - receives vertebral augmentation of the target VCF(s) using the AGN1 LOEP SV Kit
2. Active Control Group - receives vertebral augmentation of the target VCF(s) using either Stryker VertaPlex HV or Medtronic Kyphon HV-R.

Follow-up visits will be conducted at 7 days, 28 days, 3 months, 12 months and 24 months after the procedure.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)
timeFrame: 24 months
measure: Change in function
timeFrame: 24 months
measure: Radiographic evidence of implant resorption (Intervention Group only)
timeFrame: 24 months
measure: Radiographic evidence of bone formation (Intervention Group only)
timeFrame: 24 months
measure: Adverse events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Mesa
country: United States
facility: Elite Pain and Spine Institute
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Washington
country: United States
facility: GW Medical Faculty Associates
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Neurosurgery (Conquest Research)
state: Florida
city: Stuart
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Naperville
country: United States
facility: Duly Health / NextStage Clinical Research
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Wichita
country: United States
facility: Abay Neuroscience Center / NextStage Clinical Research
state: Kansas
city: Shreveport
country: United States
facility: Louisiana Spine Institute
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Medical Center (AAMC)
state: Maryland
city: Burlington
country: United States
facility: Lahey Medical Center
state: Massachusetts
city: St Louis
country: United States
facility: Washington University St. Louis
state: Missouri
city: Bronx
country: United States
facility: Montefiore
state: New York
city: New York
country: United States
facility: Mt. Sinai
state: New York
city: Pinehurst
country: United States
facility: Pinehurst Surgical Clinic
state: North Carolina
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
affiliation: Midwest Orthopedics at Rush
name: Kern Singh
role: PRINCIPAL_INVESTIGATOR
References: