PerQdisc PMCF1 Observational Trial to Evaluate the Clinical Performance and Safety of the PerQdisc Nucleus Replacement Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- PerQdisc Safety
研究概览
简要总结
PerQdisc PMCF1 is a post-market clinical follow-up observational trial to follow subjects receiving a PerQdisc spinal implant for a duration of 5 years.
详细描述
This study will be a prospective, open-label, multi-center post-market observational study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System. Primary endpoints will be used to assess the safety and efficacy of the PerQdisc device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is skeletally mature and between 21 and 60 years of age.
- •Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but must have a single level identified as the pain generator.
- •Patient has adequate disc height (6mm) at the level to be treated
- •Patient is not responsive to conservative, non-surgical treatment for back pain.
- •Patient has signed the approved Informed Consent Form.
排除标准
- •Patient has less than 6 mm of disc height.
- •Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).
- •Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.
- •Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
- •Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
- •Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to Spine Intervention Society (SIS) guidelines (diagnostic, contrast controlled).
- •Patient has any known active malignancy.
- •Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.
- •Patient has active or local systemic infection.
- •Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including Acquired Immune Deficiency Syndrome (AIDS), AIDS related Complex (ARC), and Human Immunodeficiency Virus (HIV).
- •Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
- •Patient has osteopenia of the spine (T-score of -1.0 or lower). A Bone Densiometry (DEXA) scan should be performed to rule out patients considered at risk for osteopenia.
- •Patient has morbid obesity defined as a Body Mass Index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.
- •Patient has a known allergy to silicone or barium sulfate.
- •Patient has a significant disc herniation at the level to be treated. Significant is defined as a large extruded herniation that creates a risk for expulsion.
- •Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).
- •Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
- •Protrusion of the 20A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps.
- •Patient has a violated endplate as determined by imaging balloons during fluoroscopy.
- •Patient has a disc space that is too narrow for implantation.
研究组 & 干预措施
Chronic Discogenic Low Back Pain
Patient is skeletally mature and between 21 and 60 years of age.
Patient has Degenerative Disc Disease (DDD) at one or more levels
between L1 and S1 but must have a single level identified as the pain generator.
Patient has adequate disc height (6mm) at the level to be treated
Patient is not responsive to conservative, non-surgical treatment for back pain.
干预措施: PerQdisc (Drug)
结局指标
主要结局
PerQdisc Safety
时间窗: 12 months post implant
Incidence of device expulsion and device fracture following surgery based on follow up x-rays and MRI's
PerQdisc Perfomance
时间窗: 12 months post implant
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
次要结局
- Incidence of Secondary Surgeries(6 months, 12 months, and 5 years following surgery)
- Maintenance of Disc Height(6 months, 12 months, and 5 years following surgery)
- Maintenance of Range of Motion(6 months, 12 months, and 5 years following surgery)
- Maintenance of Neurologic Status(6 months, 12 months, and 5 years following surgery)
- Use of Pain Medications(6 months, 12 months, and 5 years following surgery)