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

NCT04806360 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-05-09

No results posted yet for this study

Summary

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.

Conditions

  • Degenerative Cervical Kyphosis With Stenosis

Interventions

PROCEDURE

ACRF surgery

A new surgical procedure that previously proposed by our team.

PROCEDURE

conventional anterior surgery

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

PROCEDURE

conventional posterior surgery

Laminectomy and fusion surgery or laminoplasty surgery.

Sponsors & Collaborators

  • Naval Specialty Medical Center, China

    collaborator UNKNOWN

  • The NO.72 Army Hospital of Huzhou, China

    collaborator UNKNOWN

  • 903 Hospital of Chinese People's Liberation Army

    collaborator OTHER

  • Shanghai Changzheng Hospital

    lead OTHER

Principal Investigators

  • Xuhua Lu, M.D. · Shanghai Changzheng Hospotal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04806360 on ClinicalTrials.gov