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

Not Applicable

• Conditions: Degenerative Cervical Kyphosis With Stenosis
• Interventions: Procedure: conventional anterior surgery; Procedure: conventional posterior surgery; Procedure: ACRF surgery

• Registration Number: NCT04806360
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-09
• Study Start: 2022-09-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional anterior surgery group	conventional anterior 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.
conventional posterior surgery group	conventional posterior surgery	Eligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery.
ACRF group	ACRF 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. Eligible patients in this group will receive ACRF surgery.

Primary Outcome Measures

Name	Time	Method
Change of Neck Disability Index (NDI)	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.
Change of Cross-sectional area of the spinal canal	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.
Change of Japanese Orthopaedic Association Score (JOA)	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.
Change of Sagittal Lordosis Angle	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.

Secondary Outcome Measures

Name	Time	Method
Change of Range of Motion	baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment	Measured by dynamic X-Ray image.
Change of Pain Scores on the Visual Analog Scale (VAS)	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.
Complication rate	baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment	Any complications related to surgery will be recorded.
Reoperation rate	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.

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China