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

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ClinicalTrials.gov Identifier: NCT04806360
Recruitment Status : Not yet recruiting
First Posted : March 19, 2021
Last Update Posted : March 19, 2021
Sponsor:
Collaborators:
Naval Characteristic Medical Center
The 72nd Army Hospital of Huzhou
Hangzhou 903 Hospital
Information provided by (Responsible Party):
Xuhua Lu, Shanghai Changzheng Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Degenerative Cervical Kyphosis With Stenosis Procedure: ACRF surgery Procedure: conventional anterior surgery Procedure: conventional posterior surgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis：a Multicenter Randomized Controlled Trial
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ACRF group
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.
 Procedure: ACRF surgery
A new surgical procedure that previously proposed by our team.
Active Comparator: conventional anterior surgery group
Eligible patients in this group will receive conventional anterior surgery, including anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
 Procedure: conventional anterior surgery
Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
Active Comparator: conventional posterior surgery group
Eligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery.
 Procedure: conventional posterior surgery
Laminectomy and fusion surgery or laminoplasty surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Change of Japanese Orthopaedic Association Score (JOA) [ Time Frame: 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.

  2. Change of Neck Disability Index (NDI) [ Time Frame: 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.

  3. Change of Sagittal Lordosis Angle [ Time Frame: 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.

  4. Change of Cross-sectional area of the spinal canal [ Time Frame: 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.


Secondary Outcome Measures :
  1. Reoperation rate [ Time Frame: 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.

  2. Change of Pain Scores on the Visual Analog Scale (VAS) [ Time Frame: 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.

  3. Change of Range of Motion [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment ]
    Measured by dynamic X-Ray image.

  4. Complication rate [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment ]
    Any complications related to surgery will be recorded.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806360


Contacts
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Contact: Xuhua Lu, M.D. +862181885793 xuhualu@hotmail.com
Contact: Bangke Zhang, M.D. +8618301783716 zbk12345@163.com

Locations
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China
Shanghai Changzheng Hospital
Shanghai, China, 200003
Sponsors and Collaborators
Shanghai Changzheng Hospital
Naval Characteristic Medical Center
The 72nd Army Hospital of Huzhou
Hangzhou 903 Hospital
Investigators
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Principal Investigator: Xuhua Lu, M.D. Shanghai Changzheng Hospotal
More Information
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Responsible Party: Xuhua Lu, Director of Traumatic Orthopaedic Department, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT04806360    
Other Study ID Numbers: 2020YLCYJ-Y09
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kyphosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Curvatures
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases