Clinical and Radiological Outcomes of Posterior Cervical Fusion with Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Upper and Lower Extremity Motor Exam
研究概览
简要总结
This study is being done to prospectively collect data on subjects having posterior cervical fusion surgery using the Medtronic Infinity system. Researchers plan to collect information from patients having this type of surgery in order to learn more about patient how patients do after the surgery, including the rate of bone healing following surgery.
The goal is for 250 patients to take part in the study or for 500 screws to be used, whichever comes first. Each patient will need a varying amount of screws to be used during their surgery. Because we are measuring the accuracy of each individual screw and the surgeon will likely use multiple screws during each surgery, it is likely that the study will reach its goal of 500 screws before 250 patients are enrolled in the study.
详细描述
This is a prospective single arm study of clinical and radiological outcomes as well as surgical data from posterior cervical fusion for treating degenerative disc disease (DDD). Patients undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled.
Patients will be enrolled up to 250 patients (at maximum) or 500 screws, whichever is achieved first. This will adequately power the study assuming 95% screw accuracy, which is in line with published data, and assuming precision of +/- 2% with a confidence level of 9%.
The primary objective of this study is to show that the Medtronic Infinity System is safe and effective in posterior cervicothoracic fusion surgeries. Outcomes measures and complication rates will be compared to historical controls. Secondary objectives include screw accuracy rates/revision rates which can also be compared to historical controls. Other secondary objectives aim to clarify the workflow and operative time of using the O-arm and Stealth navigation for these types of cases.
Subjects will be monitored for adverse events throughout the duration of the study, particularly at and around the time of standard of care clinical assessments. The number of CT related adverse events will be evaluated. The monitoring will be performed by the investigator and study clinical research coordinator. The monitoring will occur both when a quarter and a half of the study patients have been enrolled. The study will be stopped should any significant CT related adverse events be identified.
The following data will be collected
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic).
- •Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
排除标准
- •Traumatic injury
- •Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
- •Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- •Clinically diagnosed osteoporosis
- •Recent (<3 yrs) or co-incident spinal tumor or infection
- •Concurrent involvement in another investigational drug or device study that could confound study data
- •History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
- •Subjects who are pregnant or plan to become pregnant in the next 24 months
- •Other contraindications for Medtronic Infinity System
结局指标
主要结局
Upper and Lower Extremity Motor Exam
时间窗: 49 Days
MMT Score 1-5 where higher score represents better outcome
PROMIS - 29 Profile v2.0 Physical Functioning Subscore
时间窗: 49 Days
Disease non-specific measure of health related physical functioning presented as T-scores with a mean of 50 and standard deviation of 10 with a higher score indicating better outcome
PROMIS - 29 Profile v2.0 Pain Intensity Subscore
时间窗: 49 Days
Disease non-specific measure of health related pain intensity presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
Reflexes Score
时间窗: 49 Days
Reflex Score 0-4 where a score of 2 represents best outcome
Cervical Sagittal Alignment
时间窗: 49 Days
Cervical Sagittal Alignment measured on pre- and post-operative radiographs
Related Adverse Events
时间窗: 49 Days
All Procedure related adverse events
Sensory Function
时间窗: 49 Days
Sensory Function Score 0-2 where higher score represents better outcome
PROMIS - 29 Profile v2.0 Anxiety Subscore
时间窗: 49 Days
Disease non-specific measure of health related anxiety presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
PROMIS - 29 Profile v2.0 Depression Subscore
时间窗: 49 Days
Disease non-specific measure of health related depression presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
PROMIS - 29 Profile v2.0 Sleep Subscore
时间窗: 49 Days
Disease non-specific measure of health related sleep presented as T-scores with a mean of 50 and standard deviation of 10 with a higher score indicating better outcome
Hoffmann's Response Test
时间窗: 49 Days
Hoffmann's Response Test measured as Positive or Negative with negative representing the better outcome
Spurling's Compression Test
时间窗: 49 Days
Spurling's Compression Test measured a Positive or Negative with negative representing the better outcome
All Adverse Events
时间窗: 49 Days
All Adverse Events and Serious Adverse Events for study duration
PROMIS - 29 Profile v2.0 Ability to Participate Subscore
时间窗: 49 Days
Disease non-specific measure of health related ability to participate presented as T-scores with a mean of 50 and standard deviation of 10 with a higher score indicating better outcome
PROMIS - 29 Profile v2.0 Fatigue Subscore
时间窗: 49 Days
Disease non-specific measure of health related fatigue presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
次要结局
- Modified Gerzbein & Robbins Scale(49 Days)
- Screw Placement Time(49 Days)
- Perioperative AEs(30 Days)
- Reference Frame Setup (Level of positioning)(49 Days)
- OR Time(30 Days)
- Blood Loss(30 Days)
- Screw Intra-op Repositioning Rate(49 Days)
- Length of Stay(30 Days)
研究者
Andrew Grossbach
Principal Investigator / Assistant Clinical Professor
Ohio State University