Clinical trial NCT04056520: Clinical and Radiological Outcomes of Posterior Cervical Fusion with Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Official title: Clinical and Radiological Outcomes of Posterior Cervical Fusion with Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-08-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled.

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Related Adverse Events
timeFrame: 49 Days
measure: Upper and Lower Extremity Motor Exam
timeFrame: 49 Days
measure: Sensory Function
timeFrame: 49 Days
measure: Reflexes Score
timeFrame: 49 Days
measure: PROMIS - 29 Profile v2.0 Physical Functioning Subscore
timeFrame: 49 Days
measure: PROMIS - 29 Profile v2.0 Ability to Participate Subscore
timeFrame: 49 Days
measure: PROMIS - 29 Profile v2.0 Anxiety Subscore
timeFrame: 49 Days
measure: PROMIS - 29 Profile v2.0 Depression Subscore
timeFrame: 49 Days
measure: PROMIS - 29 Profile v2.0 Fatigue Subscore
timeFrame: 49 Days
measure: PROMIS - 29 Profile v2.0 Sleep Subscore
timeFrame: 49 Days
measure: PROMIS - 29 Profile v2.0 Pain Intensity Subscore
timeFrame: 49 Days
measure: Cervical Sagittal Alignment
timeFrame: 49 Days
measure: Hoffmann's Response Test
timeFrame: 49 Days
measure: Spurling's Compression Test
timeFrame: 49 Days
measure: All Adverse Events
timeFrame: 49 Days
Secondary outcomes:
measure: Modified Gerzbein & Robbins Scale
timeFrame: 49 Days
measure: Screw Placement Time
timeFrame: 49 Days
measure: Screw Intra-op Repositioning Rate
timeFrame: 49 Days
measure: Reference Frame Setup (Level of positioning)
timeFrame: 49 Days
measure: Perioperative AEs
timeFrame: 30 Days
measure: OR Time
timeFrame: 30 Days
measure: Blood Loss
timeFrame: 30 Days
measure: Length of Stay
timeFrame: 30 Days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Andrew Grossbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waschke A, Walter J, Duenisch P, Reichart R, Kalff R, Ewald C. CT-navigation versus fluoroscopy-guided placement of pedicle screws at the thoracolumbar spine: single center experience of 4,500 screws. Eur Spine J. 2013 Mar;22(3):654-60. doi: 10.1007/s00586-012-2509-3. Epub 2012 Sep 23.
citation: Silbermann J, Riese F, Allam Y, Reichert T, Koeppert H, Gutberlet M. Computer tomography assessment of pedicle screw placement in lumbar and sacral spine: comparison between free-hand and O-arm based navigation techniques. Eur Spine J. 2011 Jun;20(6):875-81. doi: 10.1007/s00586-010-1683-4. Epub 2011 Jan 21.
citation: Luther N, Iorgulescu JB, Geannette C, Gebhard H, Saleh T, Tsiouris AJ, Hartl R. Comparison of navigated versus non-navigated pedicle screw placement in 260 patients and 1434 screws: screw accuracy, screw size, and the complexity of surgery. J Spinal Disord Tech. 2015 Jun;28(5):E298-303. doi: 10.1097/BSD.0b013e31828af33e.
citation: Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 Jan;15(1):11-4. doi: 10.1097/00007632-199001000-00004.