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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

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

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

NCT ID

NCT04806360

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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

xuhualu@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bangke Zhang, M.D.

Phone

+8618301783716

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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