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Interbody Device

Spira-C Interbody Device for Cervical Disc Disease (ACDF Trial)

N/A

Waitlist Available

Led By Jad G Khalil, MD

Research Sponsored by William Beaumont Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months postoperative

Awards & highlights

ACDF Trial Summary

This trial is testing a new 3-D printed titanium interbody device for treating degenerative disc disease and spinal stenosis of the cervical spine. The primary goal is to see if the device leads to fusion or bony healing. Patient reported outcomes like pain, function, and quality of life will also be measured.

Eligible Conditions

Cervical Disc Disease
Cervical Radiculopathy

ACDF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Successful Cervical Fusion Measured Radiographically

Secondary outcome measures

Count of Participants With Development of Pseudoarthrosis by Month 12

Count of Participants With Revision Surgery by Month 12

Decreased Neck Disability Index for Pain and Function

+4 more

ACDF Trial Design

1Treatment groups

Experimental Treatment

Group I: Spira-C Interbody DeviceExperimental Treatment1 Intervention

40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device

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Who is running the clinical trial?

Camber Spine TechnologiesIndustry Sponsor

1 Previous Clinical Trials

100 Total Patients Enrolled

William Beaumont HospitalsLead Sponsor

149 Previous Clinical Trials

112,845 Total Patients Enrolled

Jad G Khalil, MDPrincipal InvestigatorWilliam Beaumont Hospitals

2 Previous Clinical Trials

96 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being enrolled into this experiment?

"Perusal of clinicaltrials.gov reveals that this trial, first posted in October 2019 and last updated at the end of June 2022, is not currently seeking participants. Luckily, there are 52 other medical studies actively recruiting patients."

Answered by AI

Recent research and studies

SpineJournal

Risk Factors for Postoperative Subsidence of Single-level Anterior Cervical Discectomy and Fusion

Lee, Young-Seok, Young-Baeg Kim, and Seung-Won Park. 2014. “Risk Factors for Postoperative Subsidence of Single-level Anterior Cervical Discectomy and Fusion”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/brs.0000000000000400.

Journal of Clinical NeuroscienceJournal

Titanium Vs. Polyetheretherketone (PEEK) Interbody Fusion: Meta-analysis and Review of the Literature

Seaman, Scott, Panagiotis Kerezoudis, Mohamad Bydon, James C. Torner, and Patrick W. Hitchon. 2017. “Titanium Vs. Polyetheretherketone (PEEK) Interbody Fusion: Meta-analysis and Review of the Literature”. Journal of Clinical Neuroscience. Elsevier BV. doi:10.1016/j.jocn.2017.06.062.

The Spine JournalJournal

Bony Ingrowth Potential of 3d-printed Porous Titanium Alloy: A Direct Comparison of Interbody Cage Materials in an in Vivo Ovine Lumbar Fusion Model

McGilvray, Kirk C., Jeremiah Easley, Howard B. Seim, Daniel Regan, Sigurd H. Berven, Wellington K. Hsu, Thomas E. Mroz, and Christian M. Puttlitz. 2018. “Bony Ingrowth Potential of 3d-printed Porous Titanium Alloy: A Direct Comparison of Interbody Cage Materials in an in Vivo Ovine Lumbar Fusion Model”. The Spine Journal. Elsevier BV. doi:10.1016/j.spinee.2018.02.018.

BMC Musculoskeletal DisordersJournal