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

NCT04056520 | Completed FDA Device

• 1 other identifier: 2019H0161
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (8)

• Modified Gerzbein & Robbins Scale

  49 Days

• Screw Placement Time

  49 Days

• Screw Intra-op Repositioning Rate

  49 Days

• Reference Frame Setup (Level of positioning)

  49 Days

• Perioperative AEs

  30 Days

Study Arms (1)

Arm 1

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

Interventions

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

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.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled.

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Medtronic: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

• 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.

  PMID: 23001415 BACKGROUND

• 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.

  PMID: 21253780 BACKGROUND

• 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.

  PMID: 23511642 BACKGROUND

• 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.

  PMID: 2326693 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Andrew Grossbach, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Assistant Clinical Professor

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 14, 2019
• Study Start: September 1, 2019
• Primary Completion: November 30, 2023
• Study Completion: December 13, 2024
• Last Updated: March 21, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)