Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis

NCT ID: NCT04806360

Last Updated: 2022-05-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-30

Brief Summary

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Degenerative cervical kyphosis with stenosis (DCKS) is a common cervical spine degenerative disease, causing pain, numbness, and weakness of limbs, which seriously affect the quality of life of the patient. Surgery is an effective way to treat this condition, however, the best surgical procedure is still controversial. Anterior spinal canal reconstruction and fusion surgery (ACRF) is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. The purpose of this study is to evaluate the safety and effectiveness of ACRF surgery for treating DCKS. A multicenter prospective randomized controlled trial was designed. Eligible patients will be randomly divided into three groups, including the ACRF group, the conventional anterior surgery group, and the conventional posterior surgery group. Demographic data, surgery Information, and follow-up results will be collected and compared between groups.

Detailed Description

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Conditions

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Degenerative Cervical Kyphosis With Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACRF group

ACRF is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. Eligible patients in this group will receive ACRF surgery.

Group Type EXPERIMENTAL

ACRF surgery

Intervention Type PROCEDURE

A new surgical procedure that previously proposed by our team.

conventional anterior surgery group

Eligible patients in this group will receive conventional anterior surgery, including anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.

Group Type ACTIVE_COMPARATOR

conventional anterior surgery

Intervention Type PROCEDURE

Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.

conventional posterior surgery group

Eligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery.

Group Type ACTIVE_COMPARATOR

conventional posterior surgery

Intervention Type PROCEDURE

Laminectomy and fusion surgery or laminoplasty surgery.

Interventions

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ACRF surgery

A new surgical procedure that previously proposed by our team.

Intervention Type PROCEDURE

conventional anterior surgery

Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.

Intervention Type PROCEDURE

conventional posterior surgery

Laminectomy and fusion surgery or laminoplasty surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients are diagnosed with degenerative cervical kyphosis with stenosis
* Patients aged between 30 and 70 years
* Patients meet the indications for surgery
* Patients submitted written informed consent

Exclusion Criteria

* Tumor, infection, or trauma of the cervical spine
* Severe cervical kyphosis that greater than 50°
* Severe ossification of the posterior longitudinal ligament of the cervical spine
* Patients with ankylosing spondylitis
* Previous surgery of the cervical spine
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Naval Specialty Medical Center, China

UNKNOWN

Sponsor Role collaborator

The NO.72 Army Hospital of Huzhou, China

UNKNOWN

Sponsor Role collaborator

903 Hospital of Chinese People's Liberation Army

OTHER

Sponsor Role collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xuhua Lu

Director of Traumatic Orthopaedic Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuhua Lu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospotal

Locations

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Shanghai Changzheng Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Xuhua Lu, M.D.

Role: CONTACT

+862181885793

Bangke Zhang, M.D.

Role: CONTACT

+8618301783716

Other Identifiers

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2020YLCYJ-Y09

Identifier Type: -

Identifier Source: org_study_id

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