Single Level Anterior Cervical Corpectomy Without Posterior Stabilization

July 27, 2022 updated by: Ahmed Ragab Hassan Alshemy, Assiut University
evaluate and assess short term outcome of treating degenerative and non-degenerative cervical conditions with single level anterior cervical corpectomy without posterior fusion

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Procedure: anterior cervical corpectomy and fusion
removal of damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological parameter
Time Frame: Baseline
  • Bony fusion with no metal failure
  • presence of trabecular bridging and/or absence of motion
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological parameter
Time Frame: baseline
Percentage of improvement in NDI following surgical treatment during the follow up visits
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • spine surgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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