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

Primary Purpose

Degenerative Cervical Kyphosis With Stenosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ACRF surgery
conventional anterior surgery
conventional posterior surgery
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Cervical Kyphosis With Stenosis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Changzheng Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

ACRF group

conventional anterior surgery group

conventional posterior surgery group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Change of Japanese Orthopaedic Association Score (JOA)
Total score 0-17. The lower the score the more severe the deficits.
Change of Neck Disability Index (NDI)
Ranging from 0%-100%. A higher score indicates more patient-rated disability.
Change of Sagittal Lordosis Angle
Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
Change of Cross-sectional area of the spinal canal
Measured by MRI image. The change of cross-sectional area of the spinal canal was calculated and compared.

Secondary Outcome Measures

Reoperation rate
Any reoperation involving the same segments or adjacent segments will be calculated.
Change of Pain Scores on the Visual Analog Scale (VAS)
Ranging from 0-10. A higher score indicates more severe pain.
Change of Range of Motion
Measured by dynamic X-Ray image.
Complication rate
Any complications related to surgery will be recorded.

Full Information

First Posted
February 16, 2021
Last Updated
May 4, 2022
Sponsor
Shanghai Changzheng Hospital
Collaborators
Naval Specialty Medical Center, China, The NO.72 Army Hospital of Huzhou, China, Hangzhou 903 Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT04806360
Brief Title
Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis
Official Title
Application of Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis:a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital
Collaborators
Naval Specialty Medical Center, China, The NO.72 Army Hospital of Huzhou, China, Hangzhou 903 Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Cervical Kyphosis With Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACRF group
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional anterior surgery group
Arm Type
Active Comparator
Arm Description
Eligible patients in this group will receive conventional anterior surgery, including anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
Arm Title
conventional posterior surgery group
Arm Type
Active Comparator
Arm Description
Eligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery.
Intervention Type
Procedure
Intervention Name(s)
ACRF surgery
Intervention Description
A new surgical procedure that previously proposed by our team.
Intervention Type
Procedure
Intervention Name(s)
conventional anterior surgery
Intervention Description
Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
Intervention Type
Procedure
Intervention Name(s)
conventional posterior surgery
Intervention Description
Laminectomy and fusion surgery or laminoplasty surgery.
Primary Outcome Measure Information:
Title
Change of Japanese Orthopaedic Association Score (JOA)
Description
Total score 0-17. The lower the score the more severe the deficits.
Time Frame
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Title
Change of Neck Disability Index (NDI)
Description
Ranging from 0%-100%. A higher score indicates more patient-rated disability.
Time Frame
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Title
Change of Sagittal Lordosis Angle
Description
Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
Time Frame
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Title
Change of Cross-sectional area of the spinal canal
Description
Measured by MRI image. The change of cross-sectional area of the spinal canal was calculated and compared.
Time Frame
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Secondary Outcome Measure Information:
Title
Reoperation rate
Description
Any reoperation involving the same segments or adjacent segments will be calculated.
Time Frame
1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Title
Change of Pain Scores on the Visual Analog Scale (VAS)
Description
Ranging from 0-10. A higher score indicates more severe pain.
Time Frame
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Title
Change of Range of Motion
Description
Measured by dynamic X-Ray image.
Time Frame
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Title
Complication rate
Description
Any complications related to surgery will be recorded.
Time Frame
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuhua Lu, M.D.
Phone
+862181885793
Email
xuhualu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bangke Zhang, M.D.
Phone
+8618301783716
Email
zbk12345@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuhua Lu, M.D.
Organizational Affiliation
Shanghai Changzheng Hospotal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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