Cervical Spine FusionNCT05479864
Single Level Anterior Cervical Corpectomy Without Posterior Stabilization
A study testing anterior cervical corpectomy and fusion in people with Cervical Spine Fusion, run by Assiut University.
Trial summary
evaluate and assess short term outcome of treating degenerative and non-degenerative cervical conditions with single level anterior cervical corpectomy without posterior fusion Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Spine Fusion
- What is being tested?
- anterior cervical corpectomy and fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with degenerative and non-degenerative cervical conditions (trauma, tumors and infections) treated with "single level anterior cervical corpectomy without posterior fusion
Who cannot join
- Patients who refuse to participate in the study
- Patients who are not available for 6 months follow up
Trial locations and contacts
No sites are listed yet.
About this study
evaluate and assess short term outcome of treating degenerative and non-degenerative cervical conditions with single level anterior cervical corpectomy without posterior fusion
Read the detailed description
Cervical corpectomy is a procedure that removes damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves. Various graft materials or spacers are used to maintain height and stability followed by anterior plating. It has an important role in the management of various degenerative, traumatic, neoplastic and infectious disorders of cervical spine.
While ACCF effectively decompresses the spinal cord, it is debated whether it can provide enough cervical stability, or an additional posterior fixation (PF) is required. Studies show that in multi-level anterior cervical corpectomy, additional posterior fixation provides extra support to improve cervical stability whether it is performed initially, or later as a supplementary surgery if material failure or instability occurred, On the other hand, in single level corpectomy, it remains controversial as single level ACCF showed sufficient stability in the majority of cases without additional support but pathologies affecting bone quality like infections and neoplasms seemed to be risk factor for construct failure and instability so additional PF was required .
- Conditions
- Cervical Spine Fusion
- Being tested
- anterior cervical corpectomy and fusion
- Medical subject headings
- Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior cervical corpectomy and fusionProcedure or surgery
removal of damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves
| Study group | Role | What they receive |
|---|---|---|
| Anterior cervical corpectomy and fusion | Other | removal of damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves. Various graft materials or spacers are used to maintain height and stability followed by anterior plating Receives: Procedure: anterior cervical corpectomy and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological parameter
- Bony fusion with no metal failure
- presence of trabecular bridging and/or absence of motion
Measured: Baseline
Secondary outcomes (1)
Physiological parameter
Percentage of improvement in NDI following surgical treatment during the follow up visits
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Spine FusionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ragab Hassan Alshemy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479864
- Sponsor's protocol ID
- spine surgery
- Status last verified
- Jul 2022
- First submitted
- 8 Apr 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nouri A, Tetreault L, Singh A, Karadimas SK, Fehlings MG. Degenerative Cervical Myelopathy: Epidemiology, Genetics, and Pathogenesis. Spine (Phila Pa 1976). 2015 Jun 15;40(12):E675-93. doi: 10.1097/BRS.0000000000000913.
PubMed 25839387Perez-Cruet MJ, Samartzis D, Fessler RG. Anterior cervical discectomy and corpectomy. Neurosurgery. 2006 Apr;58(4 Suppl 2):ONS-355-9; discussion ONS-359. doi: 10.1227/01.NEU.0000205285.20336.C2.
PubMed 16582660
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Level Anterior Cervical Corpectomy Without Posterior Stabilization
- ClinicalTrials.gov ID
- NCT05479864
- Acronym / sponsor ID
- spine surgery
- Conditions
- Cervical Spine Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 29 Jul 2022 (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.
evaluate and assess short term outcome of treating degenerative and non-degenerative cervical conditions with single level anterior cervical corpectomy without posterior fusion
Detailed description
Cervical corpectomy is a procedure that removes damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves. Various graft materials or spacers are used to maintain height and stability followed by anterior plating. It has an important role in the management of various degenerative, traumatic, neoplastic and infectious disorders of cervical spine.
While ACCF effectively decompresses the spinal cord, it is debated whether it can provide enough cervical stability, or an additional posterior fixation (PF) is required. Studies show that in multi-level anterior cervical corpectomy, additional posterior fixation provides extra support to improve cervical stability whether it is performed initially, or later as a supplementary surgery if material failure or instability occurred, On the other hand, in single level corpectomy, it remains controversial as single level ACCF showed sufficient stability in the majority of cases without additional support but pathologies affecting bone quality like infections and neoplasms seemed to be risk factor for construct failure and instability so additional PF was required .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior cervical corpectomy and fusion | Other | Procedure: anterior cervical corpectomy and fusionremoval of damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves. Various graft materials or spacers are used to maintain height and stability followed by anterior plating |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with degenerative and non-degenerative cervical conditions (trauma, tumors and infections) treated with "single level anterior cervical corpectomy without posterior fusion
Key exclusion criteria (2 listed)
- Patients who refuse to participate in the study
- Patients who are not available for 6 months follow up
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 |
|---|---|---|
| anterior cervical corpectomy and fusionremoval of damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves | Procedure or surgery | Anterior cervical corpectomy and fusion |
Primary outcome
Radiological parameter
Time frame: Baseline
* Bony fusion with no metal failure * presence of trabecular bridging and/or absence of motion
1 secondary outcome
Physiological parameter
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Background: PubMed 25839387Nouri A, Tetreault L, Singh A, Karadimas SK, Fehlings MG. Degenerative Cervical Myelopathy: Epidemiology, Genetics, and Pathogenesis. Spine (Phila Pa 1976). 2015 Jun 15;40(12):E675-93. doi: 10.1097/BRS.0000000000000913.
- Background: PubMed 16582660Perez-Cruet MJ, Samartzis D, Fessler RG. Anterior cervical discectomy and corpectomy. Neurosurgery. 2006 Apr;58(4 Suppl 2):ONS-355-9; discussion ONS-359. doi: 10.1227/01.NEU.0000205285.20336.C2.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing anterior cervical corpectomy and fusion in people with Cervical Spine Fusion, 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 1 inclusion and 2 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 29 Jul 2022. 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 ahmed alshemy (01019197672, ahmedalshemy10@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological parameter (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05479864, which also lists 2 linked publications.
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 29 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.