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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 408
- 试验地点
- 31
- 主要终点
- Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)
研究概览
简要总结
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.
详细描述
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).
- Intervention Group - receives vertebral augmentation of the target VCF(s) using the AGN1 LOEP SV Kit
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Study subjects will not be informed of their treatment group assignment at the time of randomization or at any time before the subject's last office visit. The blind will be broken only if it is necessary to protect the safety or welfare of the subject as determined by the Investigator.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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) >
- •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.
研究组 & 干预措施
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.
干预措施: Treatment Group: AGN1 LOEP SV Kit (Device)
Treatment with PMMA bone cement
High viscosity PMMA bone cement will be used for vertebral augmentation.
干预措施: Control Group: PMMA bone cement (Device)
结局指标
主要结局
Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)
时间窗: 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
时间窗: 24 months
change of function from baseline as measured by the Oswestry Disability Index (ODI)
Radiographic evidence of bone formation (Intervention Group only)
时间窗: 24 months
change in bone formation from procedure as assessed by independent radiographer
Adverse events
时间窗: 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)
时间窗: 24 months
change in resorption from procedure as assessed by independent radiographer
次要结局
未报告次要终点