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

May 4, 2022 updated by: Xuhua Lu, Shanghai Changzheng Hospital

Application of Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis:a Multicenter Randomized Controlled Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Shanghai, China, 200003
        • Shanghai Changzheng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
A new surgical procedure that previously proposed by our team.
Active Comparator: 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.
Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
Active Comparator: conventional posterior surgery group
Eligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery.
Laminectomy and fusion surgery or laminoplasty surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Japanese Orthopaedic Association Score (JOA)
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Total score 0-17. The lower the score the more severe the deficits.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Neck Disability Index (NDI)
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Ranging from 0%-100%. A higher score indicates more patient-rated disability.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Sagittal Lordosis Angle
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Cross-sectional area of the spinal canal
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Measured by MRI image. The change of cross-sectional area of the spinal canal was calculated and compared.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation rate
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Any reoperation involving the same segments or adjacent segments will be calculated.
1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Pain Scores on the Visual Analog Scale (VAS)
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Ranging from 0-10. A higher score indicates more severe pain.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Range of Motion
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Measured by dynamic X-Ray image.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Complication rate
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Any complications related to surgery will be recorded.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xuhua Lu, M.D., Shanghai Changzheng Hospotal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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