A Prospective Study of NuCel® in Cervical Spine Fusion

Status Terminated

Clinical Trial Summary

Clinical Trial Description

The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine. Sixty subjects will participate in the study at a single clinical site. Participants will be at least 21 years of age. All subjects will have been established with cervical spine disease at one, two or three levels of the cervical spine that requires cervical interbody fusion per the opinion of the treating surgeon. The primary objective is to demonstrate that NuCel® is comparable to autograft bone graft in producing a successful, contiguous fusion at 6 months ±4 weeks post-operative when used in cervical fusion surgery. Success based on findings of cervical CT scan and plain radiographs. Additionally, Visual Analog Scale (VAS), Neck Disability Index (NDI) and patient satisfaction will be used as secondary outcome measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02381067
Study type	Interventional
Source	NuTech Medical, Inc
Contact
Status	Terminated
Phase	N/A
Start date	March 2015
Completion date	December 15, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06290908` - RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
Withdrawn	`NCT03223701` - Efficacy of Using Solum IV and BMC With GFC in TLIF	Phase 4
Recruiting	`NCT03883022` - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery	N/A
Completed	`NCT02902380` - The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery	N/A
Not yet recruiting	`NCT06024785` - Vertebropexy - Randomized-controlled Trial	N/A
Not yet recruiting	`NCT06000319` - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Completed	`NCT02558621` - New Robotic Assistance System for Spinal Fusion Surgery	N/A
Completed	`NCT02454400` - Pre-surgery Physiotherapy for Patients With Specific Low Back Pain	N/A
Completed	`NCT01377623` - Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion	N/A
Completed	`NCT00996073` - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion	Phase 2
Terminated	`NCT00974623` - Bone Graft Materials Observational Registry	N/A
Completed	`NCT00022776` - Surgical Versus Nonsurgical Treatment for Spinal Stenosis	Phase 3
Completed	`NCT00320619` - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery	N/A
Completed	`NCT06060821` - Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
Recruiting	`NCT04552145` - Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis	N/A
Active, not recruiting	`NCT04379921` - Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch	N/A
Withdrawn	`NCT04315090` - Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
Completed	`NCT04591249` - Physical Activity Intervention for Patients Following Lumbar Spine Surgery	N/A
Recruiting	`NCT04601363` - Personalized Spine Study Group (PSSG) Registry
Completed	`NCT04193488` - Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery	N/A