Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior

Status Recruiting

Clinical Trial Summary

This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of Cervical Spine 2 to Thoracic 1 (C2-T1) and diagnosed with degenerative disc disease will be screened for the study.

Clinical Trial Description

Degenerative disc disease of the cervical (neck) spine occurs when the discs between the vertebral bony bodies start to deteriorate or break down due to wear and tear over time. It is diagnosed as such once it is symptomatic and causes neck pain and radiculopathy (arm pain, weakness, and/or numbness). In order to correct the damaged disc and resolve radicular symptoms, anterior cervical discectomy and fusion surgery is commonly performed. This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of C2-T1 and diagnosed with degenerative disc disease will be screened for the study. Subjects will be followed up postoperatively per standard of care at 6-weeks, 3-monts, 6-months, 12-months and at 24-months at the private practice or hospital clinic. The primary end-point is Successful cervical spinal fusion as measured by dynamic (flexion and extension) x-rays and CT scan (using metal subtraction) at 12 months and as evidenced by the following three criteria: bony bridging, no presence of radiolucency, and no development of pseudoarthrosis at the treated cervical level. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04214535
Study type	Interventional
Source	William Beaumont Hospitals
Contact	Grace San Agustin, RN
Phone	248-551-6679
Email	grace.sanagustin@beaumont.org
Status	Recruiting
Phase	N/A
Start date	May 5, 2021
Completion date	December 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04848376` - Post-Market Clinical Follow-up Study of A-SPINE's Products
Active, not recruiting	`NCT05114135` - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)	N/A
Suspended	`NCT04735185` - Stem Cells vs. Steroids for Discogenic Back Pain	N/A
Withdrawn	`NCT03223701` - Efficacy of Using Solum IV and BMC With GFC in TLIF	Phase 4
Completed	`NCT04057235` - Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Not yet recruiting	`NCT06000319` - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Active, not recruiting	`NCT02969616` - Trinity Elite in Lumbar Fusion
Completed	`NCT02558621` - New Robotic Assistance System for Spinal Fusion Surgery	N/A
Completed	`NCT02104167` - Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Completed	`NCT00965380` - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
Terminated	`NCT00974623` - Bone Graft Materials Observational Registry	N/A
Completed	`NCT00996073` - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion	Phase 2
Completed	`NCT00758719` - Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Completed	`NCT00165893` - Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease	Phase 4
Terminated	`NCT01494493` - Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease	N/A
Recruiting	`NCT04727385` - Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease	N/A
Completed	`NCT04849429` - Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain	Phase 1
Recruiting	`NCT04469387` - Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion	N/A
Recruiting	`NCT04056520` - Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Completed	`NCT04119466` - Stabilizing Training in Degenerative Disc Disease	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels — STRYKER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms