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

Summary

Participation Requirements

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 en...

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

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