A Prospective Clinical Pilot Study Of Fusion Rates Using Spira™-C Titanium 3-D Printed Interbody Device For Anterior Cervical Discectomy And Fusion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Successful Cervical Fusion Measured Radiographically
研究概览
简要总结
The objective of this study is to perform a prospective, single-arm clinical evaluation utilizing the Spira™-C 3-D printed titanium interbody device for treatment of degenerative disc disease and spinal stenosis of the cervical spine to evaluate fusion status and patient reported outcomes. The primary objective is fusion status or bony healing within the device. Patient reported outcomes, i.e. pain, function, and quality of life will also be measured postoperatively.
详细描述
This is a post-market, single-arm, prospective clinical study to evaluate fusion status and patient reported outcomes using the Spira-C titanium interbody cage for degenerative disc disease where single-level ACDF surgery is indicated. The treatment group will consist of 40 subjects treated with the Spira™-C interbody device at one level. Patients with a diagnosis of cervical degenerative disc disease and/or spinal stenosis, radiculopathy or myelopathy and planning to undergo a 1-level ACDF surgery between C3-C7 will be screened and consented, if eligibility requirements are met. Once the subject has been enrolled and the surgery has taken place; data will be collected regarding the surgical details will be collected. Subjects will be followed up postoperatively at 6-weeks, 3-months, 6-months, and 12-months as per standard of care, at the private practice or clinic. Subjects will be asked to complete questionnaires regarding pain, function, and quality of life before and after surgery during the postoperative follow-up visits. Radiographic assessments will be performed at all postoperative visits; fusion status will be measured using cervical x-rays and CT scan at 12 months. Radiographs will also be utilized to assess for device-related complications, including implant failure. Any clinically significant complications related to the device will be recorded as an adverse event. This study design reflects the current standard of care for cervical degenerative disc disease and spinal stenosis with symptoms of radiculopathy or myelopathy. Data collected from subjects treated with the Spira™-C Interbody Device will be compared to historical data based on literature review of polyetheretherketone (PEEK) cage fusion rates and patient reported outcomes. Anterior cervical discectomy and fusion using an interbody device with plate and screw fixation is the treatment of choice after conservative therapies (non-surgical, i.e., physical therapy, epidural steroid injections, pain medications) have been exhausted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age and skeletally mature
- •Able to provide consent
- •Undergoing a primary, single-level ACDF between C3-C7
- •Diagnosis of symptomatic degenerative disc disease
- •Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4cm (0-10cm scale)
- •Baseline Neck Disability Index score of ≥ 20
- •Attempted at least 6-weeks of conservative non-operative treatment
排除标准
- •Any prior history of cervical fusion
- •Requires cervical fusion of more than one level
- •Acute cervical spine trauma requiring immediate intervention
- •Active systemic bacterial or fungal infection or infection at the operative site
- •History of vertebral fracture or osteoporotic fracture
- •Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid therapy
- •History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery
- •Psychological or physical condition in the opinion of the investigator that would interfere with completing study participation including completion of patient reported outcomes
- •History of neurological condition in the opinion of the investigator that may affect cervical spine function and pain assessments
- •Subjects with a history of cancer must be disease free for at least 3 years; with the exception of squamous cell skin carcinoma
- •Pregnant, or plans on becoming pregnant
- •History of allergy to titanium
结局指标
主要结局
Successful Cervical Fusion Measured Radiographically
时间窗: 12 months postoperative
Count of participants with successful cervical fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no development of pseudoarthrosis, and no presence of radiolucency at the treated cervical level
次要结局
- Decreased Neck Disability Index for Pain and Function(12 months postoperative)
- Count of Participants With Development of Pseudoarthrosis by Month 12(12 months postoperative)
- Decreased Visual Analog Scale for Neck Pain(12 months postoperative)
- Eating Assessment Tool-10 for Dysphagia(12 months postoperative)
- Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)(12 months postoperative)
- Worsening Neurological Deficit Per Cervical Spine Examination(12 months postoperative)
- Count of Participants With Revision Surgery by Month 12(12 months postoperative)
研究者
Jad Khalil MD
Orthopaedic Spine surgeon and Assistant Professor of Orthopaedic Surgery
William Beaumont Hospitals