Real World Data Collection and Analysis on the Anterior Cervical Spine Surgery

NCT ID: NCT05602714

Last Updated: 2022-11-02

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

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2025-12-31

Brief Summary

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This observational study aims to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease

Detailed Description

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This observational study is an ambispective cohort designed. Patients who are diagnosed cervical degenerative disc disease will be selected to join in this study. Visual Analogue Scale, Japanese Orthopaedic Association Scale, Neck Disability Index, SF-36, and device related or procedure related adverse events will be recorded and compared to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease

Conditions

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Cervical Disc Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Collection Data

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients over 18 years old
2. Clinical symptoms and imaging support cervical degenerative disc diseaseļ¼›
3. Failed a minimum of 3months conservative treatment
4. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) anterior cervical spine surgery
5. Written informed consent given by subject

Exclusion Criteria

1. Patients with non-degenerative (e.g., trauma, tumor, and infection) or neuromuscular diseases (e.g., motor neuron disease) were excluded
2. Patients with cervical spine X-ray film and CT scan contraindications
3. Women who are lactating and pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bingxuan Dr. Wu, PhD

Role: CONTACT

+8615210063292

Facility Contacts

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Bingxuan Wu, PhD

Role: primary

+8615210063292

Other Identifiers

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KY201402502

Identifier Type: -

Identifier Source: org_study_id

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