Clinical Trials Logo

Clinical Trial Summary

- Evaluation of outcome of DCI in treatment of cervical disc disease to patients admitted to neurosurgery department, Asyut University Hospitals. - Give the effective treatment, pain control and can detect the best method could be used. - Improve the outcome of these patients and decease rate of recurrence and complications.


Clinical Trial Description

Anterior cervical decompression and fusion (ACDF) is the traditional method for treating degenerative cervical disc disease, providing satisfactory results in a high proportion of patients. However, stabilization of the treated segment may result in loss of mobility as a functional spinal unit and acceleration of degeneration of the adjacent disc. Re operations may be required to treat complications of fusion, such as recurrent radicular symptoms, non-union, graft collapse, or expulsion. Many previous studies have shown that loss of motion at the fused level is compensated by increased motion at adjacent segments after ACDF, which induces a high rate of degenerative change adjacent to the fused segment. Cervical non-fusion techniques have increasingly been accepted and applied by spine surgeons. As a main component of cervical non-fusion techniques, artificial cervical disc replacement provides good ROM of the cervical spine. Dynamic cervical stabilization with the DCI is a novel treatment approach for cervical disc disease that was initially conceived as a method to combine the potential advantages of fusion and total disc replacement. The first DCI was designed by Matgé in 2002 for treating cervical spondylosis. Paradigm spine introduced the second generation DCIs in 2005. A U-shaped appearance and axial elasticity are two the most significant characteristics. A prospective study by Matgé et al. in 2009 showed that the clinical efficacy was satisfactory after DCI replacement in 102 cases of cervical spondylosis and during a 1-year follow-up; there was neither device migration nor subsidence. The basic concept of the inter-body implant is to maintain a distraction-compression mechanism and so avoid possible collapse of the disc height. This is achieved using the special titanium-alloy DCI, which is bio compatible, available in various sizes, and provided with different foot prints. The U-shaped body provides support and has tooth-like serrations that resist expulsion or retropulsion of the implant when placed into the inter-vertebral space. With the end-plate left intact, osteogenesis and bone fusion are inhibited and no further hetero-topic fusions are supposed to occur. The initial clinical and radio graphic results with the DCI appear promising as an alternative to TDR and ACDF in the treatment of cervical disc disease. It affords maximal neurological improvement, along with maintenance of excellent clinical outcomes. The potential bio-mechanical advantages of DCI include the ability to maintain device-level motion and minimize the development of adjacent-segment disease, while protecting the facet joints from excessive stresses noted with other motion-preserving devices during lateral bending, axial rotation, and extension. The surgical technique included the use of a conventional anterior cervical approach and discectomy. As reported, disc replacement with DCI is a new strategy, in between ACDF & ADR. It is an intermediate solution in the spectrum of management strategies of cervical disc diseases. Immediate dynamic stability with good clinical response and no implant-related morbidity or complications are the main advantages of this implant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04627454
Study type Interventional
Source Assiut University
Contact Fahd Abdel Sabour Ahmed Mohammed, Rdr
Phone 00201029522851
Email dfahd81@gmail.com
Status Not yet recruiting
Phase N/A
Start date November 25, 2020
Completion date December 15, 2021

See also
  Status Clinical Trial Phase
Completed NCT04597112 - Effect of Myofascial Release Technique In Patients With Unilateral Cervical Radiculopathy N/A
Recruiting NCT06102681 - Examination of the Effect of Early Mobilization on Postoperative Recovery, Pain, Quality of Life and Complication Development in Elective Minimally Invasive Spine Surgery N/A
Completed NCT03077516 - Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease
Active, not recruiting NCT04547959 - Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA® N/A
Enrolling by invitation NCT05066711 - NuVasive® ACP System Study
Active, not recruiting NCT03036007 - Physiotherapy After Anterior Cervical Spine Surgery N/A
Terminated NCT01433367 - A Clinical Trial Evaluating a Total Disc Replacement in Patients With Cervical Disc Disease N/A
Enrolling by invitation NCT04770571 - Posterior Cervical Fixation Study
Active, not recruiting NCT04520776 - A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Single Level Cervical Disc Disease N/A
Active, not recruiting NCT04564885 - A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels N/A
Not yet recruiting NCT03367039 - A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo N/A
Terminated NCT00945243 - Clinical Outcomes Study Evaluating the Zero-P PEEK N/A
Enrolling by invitation NCT05691231 - Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Recruiting NCT04623593 - Cervical Arthroplasty Cost Effectiveness Study (CACES) N/A
Withdrawn NCT04239638 - Analysis of Cervical Spinal MRI With Deep Learning
Terminated NCT03786432 - Prospective Study of Fusion Rates Using Spira-C Device for Anterior Cervical Discectomy and Fusion Surgery N/A
Completed NCT05262478 - Medium-Term Follow-Up of Alpha-D Cervical Disk Prosthesis
Completed NCT04734977 - Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy: N/A
Not yet recruiting NCT03541681 - Repeated Transforaminal Anesthetic Injections With or Without Glucocorticoid in Patients With Cervical Radiculopathy N/A
Not yet recruiting NCT03367052 - Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct. N/A