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

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Degenerative Cervical Kyphosis With Stenosis

Treatments: Procedure: ACRF surgery; Procedure: conventional anterior surgery; Procedure: conventional posterior surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04806360

2020YLCYJ-Y09

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

ACRF group

Experimental group

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.

Treatment:

Procedure: ACRF surgery

conventional anterior surgery group

Active Comparator group

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.

Treatment:

Procedure: conventional anterior surgery

conventional posterior surgery group

Active Comparator group

Description:

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

Treatment:

Procedure: conventional posterior surgery