Dynamic Cervical Implant in Treatment of Cervical Disc Disease (DCI)

November 8, 2020 updated by: Fahd Abdel Sabour Ahmed Mohammed, Assiut University

Evaluation the Safety and Effectiveness of Dynamic Cervical Implants (DCI) in Treatment of Single Level Cervical Disc Disease

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fahd Abdel Sabour Ahmed Mohammed, Rdr
  • Phone Number: 00201029522851
  • Email: dfahd81@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with single level cervical disc herniation ( C3 - C7 ).
  • Patients with cervical canal stenosis.
  • Patients with degenerative disc disease.
  • Patient with cervical disc disease not responding to medical treatment.
  • Age of the patient: any age.
  • Patients fit for surgery.

Exclusion Criteria:

  • Patients with multilevel cervical disc herniation.
  • Patients with segmental instability.
  • Patients with previous cervical spine surgery.
  • Patients with cervical kyphosis, active infection or known allergy to titanium.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dynamic cervical implant
dynamic cervical implant in treatment of cervical disc disease
Procedure: Discectomy and insertion of dynamic cervical implant in cervical disc herniation
The surgical technique included the use of a conventional anterior cervical approach and discectomy and insertion of dynamic cervical implant after discectomy without fixation
Experimental: discectomy
insertion of dynamic cervical implant post cervical discectomy single level
Procedure: Discectomy and insertion of dynamic cervical implant in cervical disc herniation
The surgical technique included the use of a conventional anterior cervical approach and discectomy and insertion of dynamic cervical implant after discectomy without fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of preoperative neck and radicular pain
Time Frame: Two days post operative
Pain measurement post op. To evaluate the effectiveness of DCI ( by Oswestry disability index ) that is measured through 10 questions each is. Scored from 0 to 5. A maximum score of 50, then multiply the results by 2 . Scores are stratified into severity: 0-20 minor disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippling bback bain, 81-100 either patients are bed ridden or they are exaggerated their symptoms.
Two days post operative
Evaluation the motor power
Time Frame: Three months
Evaluation patients' motor activity comparing preoperative and postoperative motor power.Assessment of motor function can be graded in patients able to obey commands as follows (right compared to left.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Abdel Hai Moussa Abdel Latif, prof., Assiut university hospital, neurosurgery department
  • Study Director: Ahmed Elsayed Abo Kresha, prof., Assiut university hospital, neurosurgery department
  • Study Director: Mohammed Elsayed Mahmoud, Prof., Assiut university hospital, neurosurgery department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 25, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

November 8, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 8, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCI in cervical disc disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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