STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
- Conditions
- Vertebral Compression FractureCompression FractureVertebral Compression
- Registration Number
- NCT04835428
- Lead Sponsor
- AgNovos Healthcare, LLC
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 408
-
Subject is a male or female 50 years of age or older at the time of study treatment.
-
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.
-
Each target VCF meets all of the following criteria:
- Due to diagnosed or presumed underlying osteoporosis
- T1 to L5 inclusively
- Target VCF-related pain ≤ 6 months at time of study treatment
-
Each target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline.
-
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.
-
Focal tenderness to palpation of the spinal process of each target VCF on the physical exam correlates with imaging.
-
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.
-
Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.
-
Subject is capable of giving written informed consent to participate in the study.
-
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
- At least one of the target VCF(s) is unstable, including split or burst fracture.
- Subject has a bleeding disorder.
- Subject has an active infection of the spine or surgical site.
- Subject has a bloodborne infection.
- At least one of the target VCFs is due to underlying or suspected tumor.
- At least one of the target VCFs is due to high-energy trauma.
- At least one of the target VCFs is due to osteonecrosis.
- 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.
- Subject has had any prior surgical treatment at the target vertebral level or adjacent vertebral levels.
- The pedicle(s) in the target vertebral body appears unable to safely accommodate transpedicular access instrumentation.
- Subject has neurologic symptoms, deficits, or radiculopathy related to the target VCF(s).
- Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
- Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus or spinal stenosis.
- Subject has spondylolisthesis > Grade 1 at target vertebral body(ies).
- Subject requires daily opioid medication for pain not related to the target VCF(s).
- Subject has severe cardiopulmonary deficiencies.
- Subject has a Body Mass Index (BMI) > 35.
- Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
- Subject has a history of tuberculous spondylitis.
- 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.
- Subject is on oral or parenteral immune-suppressive drugs.
- Subject has uncontrolled diabetes mellitus.
- Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min.
- Subject has a diagnosed calcium metabolism disorder.
- Subject has known allergies to calcium-based bone void fillers.
- Subject is pregnant or planning to become pregnant during participation in the study.
- 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).
- Subject is currently enrolled in another interventional clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS) 24 months Change in VCF-related pain by \> 20 mm from baseline as measured by a 100 mm Visual Analogue Scale (VAS) where 0mm is no pain, and 100mm is worst pain possible.
Change in function 24 months change of function from baseline as measured by the Oswestry Disability Index (ODI)
Radiographic evidence of bone formation (Intervention Group only) 24 months change in bone formation from procedure as assessed by independent radiographer
Adverse events 24 months Occurrence of device-related serious adverse events, device-related adverse events or serious adverse events categorized as failure or surgical intervention at the target level occurring post-treatment
Radiographic evidence of implant resorption (Intervention Group only) 24 months change in resorption from procedure as assessed by independent radiographer
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Elite Pain and Spine Institute
🇺🇸Mesa, Arizona, United States
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
GW Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Orlando Neurosurgery (Conquest Research)
🇺🇸Orlando, Florida, United States
Cleveland Clinic Florida
🇺🇸Stuart, Florida, United States
Duly Health / NextStage Clinical Research
🇺🇸Naperville, Illinois, United States
University of Kansas Medical Center Research Institute, Inc.
🇺🇸Kansas City, Kansas, United States
Abay Neuroscience Center / NextStage Clinical Research
🇺🇸Wichita, Kansas, United States
Louisiana Spine Institute
🇺🇸Shreveport, Louisiana, United States
Anne Arundel Medical Center (AAMC)
🇺🇸Annapolis, Maryland, United States
Lahey Medical Center
🇺🇸Burlington, Massachusetts, United States
Washington University St. Louis
🇺🇸St Louis, Missouri, United States
Montefiore
🇺🇸Bronx, New York, United States
Mt. Sinai
🇺🇸New York, New York, United States
Pinehurst Surgical Clinic
🇺🇸Pinehurst, North Carolina, United States
Texas Back Institute
🇺🇸Plano, Texas, United States