STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fra… (NCT04835428) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
United States408 participantsStarted 2022-05-31
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)
Timeframe: 24 months
2
Change in function
Timeframe: 24 months
3
Radiographic evidence of implant resorption (Intervention Group only)
Timeframe: 24 months
4
Radiographic evidence of bone formation (Intervention Group only)
✕. 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.