Clinical trial NCT04806360: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Cervical Kyphosis With Stenosis
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Naval Specialty Medical Center, China
name: The NO.72 Army Hospital of Huzhou, China
name: 903 Hospital of Chinese People's Liberation Army
First posted: 2021-03-19
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of Japanese Orthopaedic Association Score (JOA)
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
measure: Change of Neck Disability Index (NDI)
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
measure: Change of Sagittal Lordosis Angle
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
measure: Change of Cross-sectional area of the spinal canal
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Secondary outcomes:
measure: Reoperation rate
timeFrame: 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
measure: Change of Pain Scores on the Visual Analog Scale (VAS)
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
measure: Change of Range of Motion
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
measure: Complication rate
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
affiliation: Shanghai Changzheng Hospotal
name: Xuhua Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: