Single Level Anterior Cervical Corpectomy Without Posterior Stabilization

NCT ID: NCT05479864

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Spine Fusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anterior cervical corpectomy and fusion

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

Group Type OTHER

anterior cervical corpectomy and fusion

Intervention Type PROCEDURE

removal of damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

anterior cervical corpectomy and fusion

removal of damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- All patients with degenerative and non-degenerative cervical conditions (trauma, tumors and infections) treated with "single level anterior cervical corpectomy without posterior fusion

Exclusion Criteria

* Patients who refuse to participate in the study
* Patients who are not available for 6 months follow up
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Ragab Hassan Alshemy

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ahmed alshemy

Role: CONTACT

Phone: 01019197672

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25839387 (View on PubMed)

Perez-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.

Reference Type BACKGROUND
PMID: 16582660 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

spine surgery

Identifier Type: -

Identifier Source: org_study_id