Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT

August 27, 2022 updated by: Mahmoud Abdelrahman Saleh El Attar, Assiut University
TO Compare The Clinical And Radiographic Outcomes of DCI VS ACDF For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Anterior cervical discectomy and fusion (ACDF) is an effective and safe treatment for patients with radiculopathy and myelopathy. However, in the untreated levels adjacent to a fusion, increased motion and elevated intradiscal pressures have been reported. Some investigators have postulated that these changes may lead to an increased risk of adjacent segment degeneration (ASD). Limitations and problems with ACDF have led some investigators to explore the motion-preserving surgeries, such as cervical total disk replacement (TDR). Although TDR has been shown to reduce adjacent-level intra discal pressures and provide a more physiological overall cervical but also index- and adjacent-level range of motion (ROM) while maintaining sagittal alignment. Recent studies have also highlighted the potential limitations of TDR. Dynamic cervical implant (DCI) is a type of anterior decompression and cervical non-fusion implant that was initially conceived as a method to combine the potential advantages of fusion and TDR. The DCI is intended to provide controlled, limited flexion and extension-the primary motions in the sub axial cervical spine-that is greater than that seen with fusion, but less than that achieved with TDR .

Study Type

Interventional

Enrollment (Anticipated)

50

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

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single or multiple symptomatic cervical DDD with radiculopathy and\or mylopathy not responding to non-surgical management
  • Age older than 18 years

Exclusion Criteria:

  1. ossification of posterior longitudinal ligament
  2. facet arthritis
  3. lack of motion or instability at the level of surgery
  4. fracture
  5. infection
  6. tumors
  7. osteoprosis

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group (1) (ACDF)
All patients on this group will undergo Anterior Cervical Discectomy And Fusion
Procedure: Cervical spine surgery
A standard anterior approach was made with discectomy sparing the cartilage, and with foraminal decompression. Complete excision of the posterior longitudinal ligament was routinely performed to complete neural decompression. Trial inserters were used to identify the proper implant size. Device under sizing may lead to poor fixation and implant migration. The largest possible device that can be safely placed should be selected to maximize device- endplate contact and to gain support from the apophyseal rim. The teeth of the implant were optimally fixated to the endplate via Caspar pin compression following device insertion. The device may be replaced or changed using the same insertion instrument if final imaging demonstrated suboptimal positioning. Rinsing the implanted disc space removes rests of blood and bone dust, all potentially promoting HO
ACTIVE_COMPARATOR: Group (2) (DCI)
All patients on this group will undergo Dynamic Cervical Implant
Procedure: Cervical spine surgery
A standard anterior approach was made with discectomy sparing the cartilage, and with foraminal decompression. Complete excision of the posterior longitudinal ligament was routinely performed to complete neural decompression. Trial inserters were used to identify the proper implant size. Device under sizing may lead to poor fixation and implant migration. The largest possible device that can be safely placed should be selected to maximize device- endplate contact and to gain support from the apophyseal rim. The teeth of the implant were optimally fixated to the endplate via Caspar pin compression following device insertion. The device may be replaced or changed using the same insertion instrument if final imaging demonstrated suboptimal positioning. Rinsing the implanted disc space removes rests of blood and bone dust, all potentially promoting HO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological outcome
Time Frame: At 1 year follow up.
MRI grading for the degree of ASD (Mario Matsumato grading)
At 1 year follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome
Time Frame: At 3 month .
1-Neck Disability Index (NDI) : 10 item score from 0 to 5 maximum score is 50 , high score is worse
At 3 month .
Radiological outcome (Plain x-ray)
Time Frame: at 6 month.

1- Cervical sagittal alignment C2 to C7 (Cobb angle)

5-implant fusion described as a less than 1-mm motion between the tips of the spinous processes in dynamic radiographs and/or the presence of bridging bony trabeculae.
at 6 month.
Radiological outcome (MSCT)
Time Frame: At 1 year .
1-implant fusion
At 1 year .
clinical outcome
Time Frame: At 3 month .
Visual analogue scale (VAS) scores for neck and arm from 0 to 10 score , the higher score is worse
At 3 month .
radiological outcome
Time Frame: at 6 month .
2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment
at 6 month .

Collaborators and Investigators

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

Sponsor

Assiut University

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.

General Publications

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)

August 25, 2022

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2024

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 27, 2022

First Posted (ACTUAL)

August 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 27, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cervical Degenerative 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.

Clinical Trials on Cervical Degenerative Disc Disease

Clinical Trials on Cervical spine surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe