Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Patient demographic and pre-operative clinical information will include: Name Age Sex Race (self-reported) Vitals Height, weight and body mass index (BMI) General medical/surgical history Medication regimen Smoking status (current, former, never) History of alcohol/substance abuse PROMIS Neurological Assessment (strength, sensory, reflexes, Hoffmann's response, Spurling's test) Duration of disease X-rays, CT, and MRI as available Patient surgical details to be collected will include: Diagnosis Date of surgery Operative Index levels Operative time (incision open to close) Implants used Length of hospital stay Estimated blood loss / Surgical complications Somatosensory and motor intraoperative monitoring reports Post-operative clinical information will include: Medication regimen PROMIS Neurological Assessment (strength, sensory, reflexes, Hoffmann's response, Spurling's test) X-rays, CT, and MRI as available

Official Title
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Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 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) Exclusion Criteria: 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 Prisoner Other contraindications for Medtronic Infinity System

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br>Subjects undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled | Device: Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation system<br>* The INFINITY™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: Traumatic spinal fractures and/or traumatic dislocations. Instability or deformity. Failed previous fusions (e.g. pseudarthrosis). Tumors involving the cervical spine. Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/ or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Related Adverse Events | All Procedure related adverse events | 49 Days | 
| Upper and Lower Extremity Motor Exam | MMT Score 1-5 where higher score represents better outcome | 49 Days | 
| Sensory Function | Sensory Function Score 0-2 where higher score represents better outcome | 49 Days | 
| Reflexes Score | Reflex Score 0-4 where a score of 2 represents best outcome | 49 Days | 
| PROMIS - 29 Profile v2.0 Physical Functioning Subscore | 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 | 49 Days | 
| PROMIS - 29 Profile v2.0 Ability to Participate Subscore | 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 | 49 Days | 
| PROMIS - 29 Profile v2.0 Anxiety Subscore | 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 | 49 Days | 
| PROMIS - 29 Profile v2.0 Depression Subscore | 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 | 49 Days | 
| PROMIS - 29 Profile v2.0 Fatigue Subscore | 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 | 49 Days | 
| PROMIS - 29 Profile v2.0 Sleep Subscore | 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 | 49 Days | 
| PROMIS - 29 Profile v2.0 Pain Intensity Subscore | 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 | 49 Days | 
| Cervical Sagittal Alignment | Cervical Sagittal Alignment measured on pre- and post-operative radiographs | 49 Days | 
| Hoffmann's Response Test | Hoffmann's Response Test measured as Positive or Negative with negative representing the better outcome | 49 Days | 
| Spurling's Compression Test | Spurling's Compression Test measured a Positive or Negative with negative representing the better outcome | 49 Days | 
| All Adverse Events | All Adverse Events and Serious Adverse Events for study duration | 49 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Gerzbein & Robbins Scale | Screw placement accuracy assessed using modified Gertzbein & Robbins Scale with a score range of 0-4 with lower score indicating better outcome | 49 Days | 
| Screw Placement Time | Time to place screw | 49 Days | 
| Screw Intra-op Repositioning Rate | Rate of Screw Repositioning Intraoperatively | 49 Days | 
| Reference Frame Setup (Level of positioning) | Level of Surgical Positioning | 49 Days | 
| Perioperative AEs | Rate of Perioperative AEs within 30 days post-op | 30 Days | 
| OR Time | Time from surgical procedure start to end | 30 Days | 
| Blood Loss | Blood Loss during surgery measured in cc | 30 Days | 
| Length of Stay | Length of Hospital Stay measured in days | 30 Days |