MedDataX Logo

Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph

NCT ID: NCT03360409

Last Updated: 2017-12-04

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-06-01

Brief Summary

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

Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.

Detailed Description

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

This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.

Conditions

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

Cervical Disc Degeneration

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cervical Disc Degeneration cervical anterior discectomy Spinal alignment

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

grade 1

ACD

Group Type EXPERIMENTAL

ACD

Intervention Type PROCEDURE

Undertake anterior cervical discectomy without fusion

grade 2

ACDF

Group Type ACTIVE_COMPARATOR

ACDF

Intervention Type PROCEDURE

anterior cervical discectomy with fusion

grade 3

ACDA

Group Type ACTIVE_COMPARATOR

ACDA

Intervention Type PROCEDURE

anterior cervical discectomy with arthroplasty

Interventions

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

ACD

Undertake anterior cervical discectomy without fusion

Intervention Type PROCEDURE

ACDF

anterior cervical discectomy with fusion

Intervention Type PROCEDURE

ACDA

anterior cervical discectomy with arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* patients with arm pain not responding to conservative treatment
* lasted longer than 10 weeks
* single level disc degeneration
* mobile spine on dynamic lateral cervical X-rays

Exclusion Criteria

* severe cardiopulmonary comorbidity
* suspected underlying malignant disease
* radicular syndrome
* spinal-cord compression syndrome
* contraindication for radiography
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Zhu Zhenqi

department of spinal surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

zhenqi zhu

Role: STUDY_DIRECTOR

PekingUPH department of spinal surgery

Central Contacts

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

chen guo

Role: CONTACT

Phone: 8618055644700

Email: [email protected]

Other Identifiers

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

CACD3

Identifier Type: -

Identifier Source: org_study_id