Dynamic Cervical Implant vs. Anterior Cervical Discectomy and Fusion

Dynamic Cervical Implant (DCI) vs. Anterior Cervical Discectomy and Fusion (ACDF) in Treatment of Single-level Cervical Disc Prolapse

Comparison between Dynamic Cervical Implant as a recently introduced technique in our department and the conventional Anterior Cervical Discectomy and Fusion in management of single-level cervical disc prolapse.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Disc Prolapse
• Intervention / Treatment: Procedure: Dynamic Cervical Implant; Procedure: Anterior Cervical Discectomt and Fusion

Detailed Description

Anterior cervical discectomy and fusion (ACDF) is considered to be a highly successful surgical technique for cervical spondylosis associated with brachialgia and/or myelopathy. Non-union accounts for more than two-thirds of failures in ACDF surgeries and iliac bone graft morbidity is also reported in about one-third of multilevel fusion operations. There are many types of cages used to avoid the complications associated with iliac bone grafting.These problems include persistent donor-site pain, infection, hematoma formation, iliac crest fracture, and neuralgia parasthetica.

However, in spite of being successful for many years, ACDF has its own complications in the form of non-union, implant failure, and adjacent level disease which occurs due to the excessive motion observed at the levels immediately above and/or below the index level. It has been proven to provide clinical stability after decompression.. However, although it achieves long-term success, ACDF is not without complications as there have been reports of pseudoarthrosis, implant failure, and adjacent level disease which occurs due to the significant amount of increased motion observed at the levels immediately above and below the fusion. However, greater compensation occurred at the inferior segments compared to the superior segments for the lower level fusions.

Dynamic cervical Implant (DCI) is a titanium implant, originally invented in 2002 by Dr. Guy Matgé, Luxembourg. It was introduced in clinical use, in 2004. The design was modified to better accommodate the normal disc anatomy. The DCI implant with its motion preservation characters is unique implant. It stabilizes the cervical spine while still offering a limited, controlled flexion and extension movements allowing the spine to dynamically perform its function. It also acts as a shock absorber, preventing accelerated degeneration in adjacent segments. Thus, the DCI implant aims at combining the advantages of the gold standard "fusion" with a motion preservation philosophy.

This study aims to

• compare the clinical and radiographic outcomes of ACDF versus DCI in patients with degenerative cervical radiculopathy and/or myelopathy operated upon at Assiut University Hospital.
• Give the effective treatment, pain control and can detect the best method could be used in such cases.

I.

• Improve the outcome of these patients and decease rate of recurrence and complications

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hazem A Othman, MSc; Phone Number: 002 01060324743; Email: dr.hazem.othman1990@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with single level cervical disc prolapse in the subaxial cervical vertebrae (C3 - C7) confirmed by MRI.
2. Age of the patient is between 18- 60 years old of both sex.
3. Patients are fit for surgery..

Exclusion Criteria:

1. Patients with multilevel cervical disc prolapse.
2. Patients with recurrent disc prolapse.
3. Spinal deformity
4. Spinal instability.
5. Patients who are unfit for surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic Cervical Implant	Procedure: Dynamic Cervical Implant; Cervical discectomy through anterior approach with replacement of disc by dynamic implant
Active Comparator: Anterior Cervical Discectomt and Fusion	Procedure: Anterior Cervical Discectomt and Fusion; Cervical discectomy through anterior approach with putting of cervical cage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) of neck pain	Subjective Neck pain intensity on scale of 1-10	six months
Visual Analogue Scale (VAS) of brachialgia	Subjective brachialgia intensity on scale of 1-10	six months
Intervertebral Hight	The distance from the midpoint of the upper endplate of the upper vertebral body to the midpoint of the lower endplate of the lower vertebral body	six months
Range of motion	range of motion of affected level using Cobb's angle.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	intraoperative blood loss	immediate post operative
Hospital Stay	post operative hospital stay	up to one week

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Ahmed E Abokresha, Professor, Assiut University; Study Director: Shady A Hassaan, MD, Assiut University; Principal Investigator: Hazem A Othman, MSc, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Prolapse
• Other Study ID Numbers: DCI vs. ACDF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No