NCT06845293

Brief Summary

Adult patients with cervical degenerative diseases undergoing primary anterior and/or posterior cervical fusion will be prospectively enrolled from participating sites. Patients will be treated and followed up at the participating sites per local standard of care. Several variables related to the patient characteristics and fusion details will be collected. The mainstream study will not collect follow-up (FU) data. The duration of this patient cohort is currently planned as open ended.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
113mo left

Started Jul 2025

Longer than P75 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2025Jul 2035

First Submitted

Initial submission to the registry

February 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2035

Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

5.1 years

First QC Date

February 19, 2025

Last Update Submit

February 24, 2025

Conditions

Cervical Spine Degenerative Disease

Keywords

Cervical Spine Degenerative Diseaseprospective multicenter patient cohortanterior fusionposterior fusionClinical Study Hub

Outcome Measures

Primary Outcomes (1)

  • Form a large patient cohort

    The primary objective is to form a large prospective multicenter patient cohort with standardized data collection of key patient and treatment characteristics that will drive hypothesis generation in patients with cervical degenerative diseases.

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with cervical degenerative diseases undergoing primary anterior and/or posterior cervical fusion will be prospectively enrolled from participating sites.

You may qualify if:

  • Age 18 years and older
  • Undergoing primary surgical treatment for cervical degenerative disease
  • Ability to provide informed consent according to the IRB/EC defined and approved procedures

You may not qualify if:

  • Age under 18 years
  • Patients with spinal infection
  • Patients with spinal tumor
  • Patients with acute spinal injuries/trauma within 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 25, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2035

Last Updated

February 25, 2025

Record last verified: 2025-02