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

The Ohio State University

Status

Completed

Conditions

Degenerative Disc Disease

Treatments

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

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04056520

2019H0161

Details and patient eligibility

About

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.

Full 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

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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