Cervical Disc ProlapseNCT05101967
Dynamic Cervical Implant vs. Anterior Cervical Discectomy and Fusion
A study testing Dynamic Cervical Implant and Anterior Cervical Discectomt and Fusion in people with Cervical Disc Prolapse, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Disc Prolapse
- What is being tested?
- Dynamic Cervical Implant and Anterior Cervical Discectomt and Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with single level cervical disc prolapse in the subaxial cervical vertebrae (C3 - C7) confirmed by MRI.
- Age of the patient is between 18- 60 years old of both sex.
- Patients are fit for surgery..
Who cannot join
- Patients with multilevel cervical disc prolapse.
- Patients with recurrent disc prolapse.
- Spinal deformity
- Spinal instability.
- Patients who are unfit for surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Cervical Disc Prolapse
- Being tested
- Dynamic Cervical Implant, Anterior Cervical Discectomt and Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Cervical ImplantProcedure or surgery
Cervical discectomy through anterior approach with replacement of disc by dynamic implant
Anterior Cervical Discectomt and FusionProcedure or surgery
Cervical discectomy through anterior approach with putting of cervical cage.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Cervical Implant | Experimental | Not described Receives: Procedure: Dynamic Cervical Implant |
| Anterior Cervical Discectomt and Fusion | Active comparator | Not described Receives: Procedure: Anterior Cervical Discectomt and Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) of neck pain
Subjective Neck pain intensity on scale of 1-10
Measured: six months
Visual Analogue Scale (VAS) of brachialgia
Subjective brachialgia intensity on scale of 1-10
Measured: 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
Measured: six months
Range of motion
range of motion of affected level using Cobb's angle.
Measured: six months
Secondary outcomes (2)
Blood Loss
intraoperative blood loss
Measured: immediate post operative
Hospital Stay
post operative hospital stay
Measured: up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc ProlapseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H A Othman, Assiut University
- Investigators
- Ahmed E Abokresha, Professor, Study chair, Assiut UniversityShady A Hassaan, MD, Study director, Assiut UniversityHazem A Othman, MSc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101967
- Sponsor's protocol ID
- DCI vs. ACDF
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Cervical Implant (DCI) vs. Anterior Cervical Discectomy and Fusion (ACDF) in Treatment of Single-level Cervical Disc Prolapse
- ClinicalTrials.gov ID
- NCT05101967
- Acronym / sponsor ID
- DCI vs. ACDF
- Conditions
- Cervical Disc Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Cervical Implant | Experimental | Procedure: Dynamic Cervical Implant |
| Anterior Cervical Discectomt and Fusion | Active comparator | Procedure: Anterior Cervical Discectomt and Fusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with single level cervical disc prolapse in the subaxial cervical vertebrae (C3 - C7) confirmed by MRI.
- Age of the patient is between 18- 60 years old of both sex.
- Patients are fit for surgery..
Key exclusion criteria (5 listed)
- Patients with multilevel cervical disc prolapse.
- Patients with recurrent disc prolapse.
- Spinal deformity
- Spinal instability.
- Patients who are unfit for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Cervical ImplantCervical discectomy through anterior approach with replacement of disc by dynamic implant | Procedure or surgery | Dynamic Cervical Implant |
| Anterior Cervical Discectomt and FusionCervical discectomy through anterior approach with putting of cervical cage. | Procedure or surgery | Anterior Cervical Discectomt and Fusion |
Primary outcome
Visual Analogue Scale (VAS) of neck pain
Time frame: six months
Subjective Neck pain intensity on scale of 1-10
Visual Analogue Scale (VAS) of brachialgia
Time frame: six months
Subjective brachialgia intensity on scale of 1-10
Intervertebral Hight
Time frame: six months
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
Range of motion
Time frame: six months
range of motion of affected level using Cobb's angle.
2 secondary outcomes
Blood Loss
Time frame: immediate post operative
Hospital Stay
Time frame: up to one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed E Abokresha, Professor study chair
Assiut University
Shady A Hassaan, MD study director
Assiut University
Hazem A Othman, MSc principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Cervical Implant and Anterior Cervical Discectomt and Fusion in people with Cervical Disc Prolapse, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hazem A Othman, MSc (01060324743 ext. 002, dr.hazem.othman1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) of neck pain (time frame: six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.