Dynamic Cervical Implant vs. Anterior Cervical Discectomy and Fusion

Cervical Disc Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05101967
• Other study ID #: DCI vs. ACDF
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Hazem A Othman, MSc
• Phone: 01060324743
• Email: dr.hazem.othman1990[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Prolapse
• Intervertebral Disc Displacement
• Prolapse

Intervention

Procedure:
• Dynamic Cervical Implant
Cervical discectomy through anterior approach with replacement of disc by dynamic implant
• Anterior Cervical Discectomt and Fusion
Cervical discectomy through anterior approach with putting of cervical cage.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) of neck pain	Subjective Neck pain intensity on scale of 1-10	six months
Primary	Visual Analogue Scale (VAS) of brachialgia	Subjective brachialgia intensity on scale of 1-10	six months
Primary	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
Primary	Range of motion	range of motion of affected level using Cobb's angle.	six months
Secondary	Blood Loss	intraoperative blood loss	immediate post operative
Secondary	Hospital Stay	post operative hospital stay	up to one week