NCT05479864

Brief Summary

evaluate and assess short term outcome of treating degenerative and non-degenerative cervical conditions with single level anterior cervical corpectomy without posterior fusion

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

April 8, 2022

Last Update Submit

July 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Radiological parameter

    * Bony fusion with no metal failure * presence of trabecular bridging and/or absence of motion

    Baseline

Secondary Outcomes (1)

  • Physiological parameter

    baseline

Study Arms (1)

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

Procedure: anterior cervical corpectomy and fusion

Interventions

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

Anterior cervical corpectomy and fusion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25839387BACKGROUND
  • 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.

    PMID: 16582660BACKGROUND

MeSH Terms

Conditions

Klippel-Feil Syndrome

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

DysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 8, 2022

First Posted

July 29, 2022

Study Start

August 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

July 29, 2022

Record last verified: 2022-07