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Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament

Primary Purpose

Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ACAF
Laminoplasty
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ossification of Posterior Longitudinal Ligament focused on measuring OPLL, Cervical Spondylotic Myelopathy, ACAF, Laminoplasty, Multicenter Study

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patient's age is 18-70 years old, regardless of gender;
  2. The patient was diagnosed as severe ossification of the posterior longitudinal ligament (X-ray or CT showed ossification of the posterior longitudinal ligament); The imaging findings showed occupied ratio ≥ 60% or involved three or more segments;
  3. Symptoms of spinal cord and nerve root compression, or accompanied by spinal cord compression symptoms such as dysfunction of urination and defecation, conservative treatment was ineffective or aggravated gradually;
  4. The participant (or his legal guardian) can sign the informed consent.

Exclusion Criteria:

  1. Congenital malformations (including but not limited to occipitocervical malformations, congenital cervical fusion, cervical related neurovascular malformations), ossification of cervical ligamentum flavum, cervical trauma, cervical cancer, cervical tuberculosis and other inflammatory diseases;
  2. Patients with other spinal diseases such as thoracolumbar vertebrae that affect clinical symptoms; Patients with motor neuron diseases such as amyotrophic lateral sclerosis and other nervous system diseases;
  3. The symptoms were aggravated due to recent trauma;
  4. Patients who participated in other clinical trials in recent 3 months;
  5. The participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent;
  6. Those who are in poor health and can not tolerate surgery; The patients were not suitable for surgical treatment after preoperative examination.

Sites / Locations

  • Peking University Shenzhen HospitalRecruiting
  • The 2nd Affiliated Hospital of Harbin Medical University
  • Xuanwu Hospital Capital Medical UniversityRecruiting
  • Affiliated Hospital of Jining Medical UniversityRecruiting
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • Shanghai Changzheng HospitalRecruiting
  • Shanghai Sixth People's Hospital
  • The First Affiliated Hospital of Shanghai Jiao Tong UniversityRecruiting
  • Shanghai Tongji Hospital, School of Medicine, Tongji UniversityRecruiting
  • Shanghai Changhai Hospital
  • Shanxi Bethune HospitalRecruiting
  • The Second Affiliated Hospital, Air Force Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ACAF

Laminoplasty

Arm Description

Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion

Participants underwent posterior decompression of Laminoplasty

Outcomes

Primary Outcome Measures

C-JOA Recovery Rate
(postoperative JOA score at 3 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
C-JOA Recovery Rate
(postoperative JOA score at 6 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
C-JOA Recovery Rate
(postoperative JOA score at 12 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
C-JOA Recovery Rate
(postoperative JOA score at 24 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%

Secondary Outcome Measures

Japanese Orthopaedic Association Scores
Filling in the Japanese Orthopaedic Association Scores scale. This scale involves four aspects: upper limb motor function (range, 0 to 4 points), lower limb motor function (range, 0 to 4 points), sensory function (range, 0 to 6 points), and bladder function (range, 0 to 3 points). The total C-JOA score ranged from 0 (worst) to 17 (normal condition).
Visual Analogue Scale
Filling in the Visual Analogue Scale pain score that range, 0 [no pain] to 10 [most severe].
Neck Disability Index
Filling in the 10-item Neck Disability Index scale that totally range 0 to 50 points, the highest index the worst.
Nurick-Score
Filling in the 6-level Nurick disability grade scale that range 0 [mild] to 5 [severe].

Full Information

First Posted
July 11, 2021
Last Updated
March 28, 2023
Sponsor
Shanghai Changzheng Hospital
Collaborators
Changhai Hospital, Shanghai 6th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Tongji Hospital, Peking University Shenzhen Hospital, The Second Affiliated Hospital of Harbin Medical University, Xuanwu Hospital, Beijing, Jining Medical University, The Affiliated Hospital of Qingdao University, Shanxi Bethune Hospital, Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04968028
Brief Title
Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Official Title
An Open-label Randomized Multi-centre Study to Evaluate Anterior Controllable Antedisplacement and Fusion Versus Posterior Laminoplasty in Patients With Cervical Ossification of the Posterior Longitudinal Ligament
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Changzheng Hospital
Collaborators
Changhai Hospital, Shanghai 6th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Tongji Hospital, Peking University Shenzhen Hospital, The Second Affiliated Hospital of Harbin Medical University, Xuanwu Hospital, Beijing, Jining Medical University, The Affiliated Hospital of Qingdao University, Shanxi Bethune Hospital, Tang-Du Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy, safety and imaging outcomes between Anterior Controllable Antedisplacement and Fusion (ACAF) and Laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament.
Detailed Description
This is a national, multicenter, prospective, randomized controlled trial to compare the safety and efficacy of ACAF and posterior laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament. In this study, 164 adult patients aged 18-70 with severe copll were randomly assigned to the experimental group (using ACAF) and the control group (using lamp) according to the ratio of 1:1. The patients were followed up for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
Keywords
OPLL, Cervical Spondylotic Myelopathy, ACAF, Laminoplasty, Multicenter Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
In view of the obvious differences between the two surgery methods, this study was designed as an open-label trial. However, the results of X-ray, computed tomography (CT) and magnetic resonance imaging (MRI) will be independently reviewed by an independent radiographic review committee in a blind fashion in addition to the evaluation by site investigators.
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACAF
Arm Type
Experimental
Arm Description
Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion
Arm Title
Laminoplasty
Arm Type
Experimental
Arm Description
Participants underwent posterior decompression of Laminoplasty
Intervention Type
Procedure
Intervention Name(s)
ACAF
Other Intervention Name(s)
Anterior Controllable Antedisplacement and Fusion
Intervention Description
(1)A standard right-side Smith-Robinson approach is performed. (2) The involved disc tissues are removed. The posterior longitudinal ligament is cut down at the levels cephalic and caudal to OPLL. (3) The anterior portion of the middle vertebral bodies is removed according to the thickness of ossification. Suitable cages are placed into each intervertebral space. (4) On the left side of the vertebra, a 2-mm-wide groove is created at the medial border of the transverse foramina. After that, an curved plated is fixed with screws. (5) On the right side of the vertebrae, a similar groove was also created. (6) Finally, tightening the screws to achieve a gradual evaluation of the vertebrae with OPLL.
Intervention Type
Procedure
Intervention Name(s)
Laminoplasty
Intervention Description
(1) In the prone position, the skin and nuchal ligament were cut through the posterior median incision, and the paravertebral muscles were stripped layer by layer to expose the bilateral vertebral lamina, lateral mass and articular process.（2) Part of spinous process were removed with bone biting forceps. The side with more severe symptoms was selected as the open side, bone groove was performed at 2-3 mm of the medial edge of bilateral facet joints with the medial cortex was reserved at the shaft side.（3) Slowly lift the lamina and maintained.（4)Determining the opening width of each segment by trial, and selecting the appropriate size Arch miniplate, and fixed with screws.
Primary Outcome Measure Information:
Title
C-JOA Recovery Rate
Description
(postoperative JOA score at 3 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
Time Frame
Time point of outcome: 3 months post-operative follow-up visits
Title
C-JOA Recovery Rate
Description
(postoperative JOA score at 6 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
Time Frame
Time point of outcome: 6 months post-operative follow-up visits
Title
C-JOA Recovery Rate
Description
(postoperative JOA score at 12 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
Time Frame
Time point of outcome: 12 months post-operative follow-up visits
Title
C-JOA Recovery Rate
Description
(postoperative JOA score at 24 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
Time Frame
Time point of outcome: 24 months post-operative follow-up visits
Secondary Outcome Measure Information:
Title
Japanese Orthopaedic Association Scores
Description
Filling in the Japanese Orthopaedic Association Scores scale. This scale involves four aspects: upper limb motor function (range, 0 to 4 points), lower limb motor function (range, 0 to 4 points), sensory function (range, 0 to 6 points), and bladder function (range, 0 to 3 points). The total C-JOA score ranged from 0 (worst) to 17 (normal condition).
Time Frame
28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Title
Visual Analogue Scale
Description
Filling in the Visual Analogue Scale pain score that range, 0 [no pain] to 10 [most severe].
Time Frame
28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Title
Neck Disability Index
Description
Filling in the 10-item Neck Disability Index scale that totally range 0 to 50 points, the highest index the worst.
Time Frame
28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Title
Nurick-Score
Description
Filling in the 6-level Nurick disability grade scale that range 0 [mild] to 5 [severe].
Time Frame
28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient's age is 18-70 years old, regardless of gender; The patient was diagnosed as severe ossification of the posterior longitudinal ligament (X-ray or CT showed ossification of the posterior longitudinal ligament); The imaging findings showed occupied ratio ≥ 60% or involved three or more segments; Symptoms of spinal cord and nerve root compression, or accompanied by spinal cord compression symptoms such as dysfunction of urination and defecation, conservative treatment was ineffective or aggravated gradually; The participant (or his legal guardian) can sign the informed consent. Exclusion Criteria: Congenital malformations (including but not limited to occipitocervical malformations, congenital cervical fusion, cervical related neurovascular malformations), ossification of cervical ligamentum flavum, cervical trauma, cervical cancer, cervical tuberculosis and other inflammatory diseases; Patients with other spinal diseases such as thoracolumbar vertebrae that affect clinical symptoms; Patients with motor neuron diseases such as amyotrophic lateral sclerosis and other nervous system diseases; The symptoms were aggravated due to recent trauma; Patients who participated in other clinical trials in recent 3 months; The participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent; Those who are in poor health and can not tolerate surgery; The patients were not suitable for surgical treatment after preoperative examination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Han, Master
Phone
+86 18317028536
Email
changzhengspine@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Chen, Doctor
Phone
+86 13916821845
Email
cyspine@smmu.edu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiangang Shi, Doctor
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dan Han, Master
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yu Chen, Doctor
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binsheng Yu, Doctor
Phone
+86 13682570903
Email
hpyubinsheng@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yan Shi, Master
Phone
+86 13424384282
Email
doctor.shiyan@qq.com
Facility Name
The 2nd Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjaing
ZIP/Postal Code
150086
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinglong Yan, Doctor
Phone
+86 13069715632
Email
yjlg4@aliyun.com
First Name & Middle Initial & Last Name & Degree
Ye Ji, Doctor
Phone
+86 13633634078
Email
jiyemailbox@aliyun.com
Facility Name
Xuanwu Hospital Capital Medical University
City
Pekin
State/Province
Pekin
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zan Chen, Doctor
Phone
+86 13911712120
Email
chenzan66@163.com
First Name & Middle Initial & Last Name & Degree
Wanru Duan, Doctor
Phone
+86 13581803400
Email
duanwanru@xwhosp.org
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandong
ZIP/Postal Code
272100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weihong Zhang, Doctor
Phone
+86 15054796099
Email
spinezwh@163.com
First Name & Middle Initial & Last Name & Degree
Yanming Li, Doctor
Phone
+86 15866067775
Email
lym20050404@aliyun.com
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266555
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongming Xi, Doctor
Phone
+86 18661807802
Email
xym700118@163.com
First Name & Middle Initial & Last Name & Degree
Jiale Shao, Doctor
Phone
+86 18661806662
Email
shaojiale1119@163.com
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangang Shi, Doctor
Phone
+86 13701668346
Email
shijiangang616@163.com
First Name & Middle Initial & Last Name & Degree
Dan Han, Master
Phone
+86 18317028536
Email
changzhengspine@163.com
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianguang Xu, Doctor
Phone
+86 13701698475
Email
jianguangxu2004@aliyun.com
First Name & Middle Initial & Last Name & Degree
Guowang Zhang, Doctor
Phone
+86 18501765462
Email
zhangguowang@alumni.sjtu.edu.cn
Facility Name
The First Affiliated Hospital of Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200086
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Shen, Doctor
Phone
+86 13671877906
Email
shmail1231@yahoo.com
First Name & Middle Initial & Last Name & Degree
Liang Zhu, Doctor
Phone
+86 13818236846
Email
zhuliangspine@hotmail.com
Facility Name
Shanghai Tongji Hospital, School of Medicine, Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200333
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Ma, Doctor
Phone
+86 13564678952
Email
13564678952@163.com
First Name & Middle Initial & Last Name & Degree
Ning Xie, Doctor
Phone
+86 13601981863
Email
drnxie@163.com
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Li, Doctor
Phone
+86 13801681322
Email
limingch@21cn.com
First Name & Middle Initial & Last Name & Degree
Xiaoyi Zhou, Doctor
Phone
+86 13818909826
Email
13818909826@163.com
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haoyu Feng, Doctor
Phone
+86 13903468578
Email
fenghaoyuspine@126.com
First Name & Middle Initial & Last Name & Degree
Lin Sun, Doctor
Phone
+86 13593148640
Email
sunlin_9999@163.com
Facility Name
The Second Affiliated Hospital, Air Force Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Liao, Doctor
Phone
+86 13909256861
Email
liao_b@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiaoxiang Li, Doctor
Phone
+86 15929779234
Email
junyixiangzi@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32097261
Citation
Chen Y, Sun J, Yuan X, Guo Y, Yang H, Chen D, Shi J. Comparison of Anterior Controllable Antedisplacement and Fusion With Posterior Laminoplasty in the Treatment of Multilevel Cervical Ossification of the Posterior Longitudinal Ligament: A Prospective, Randomized, and Control Study With at Least 1-Year Follow Up. Spine (Phila Pa 1976). 2020 Aug 15;45(16):1091-1101. doi: 10.1097/BRS.0000000000003462.
Results Reference
background
PubMed Identifier
31797138
Citation
Sun K, Wang S, Huan L, Sun J, Xu X, Sun X, Shi J, Guo Y. Analysis of the spinal cord angle for severe cervical ossification of the posterior longitudinal ligament: comparison between anterior controllable antedisplacement and fusion (ACAF) and posterior laminectomy. Eur Spine J. 2020 May;29(5):1001-1012. doi: 10.1007/s00586-019-06216-6. Epub 2019 Dec 3.
Results Reference
background
PubMed Identifier
34496821
Citation
Chen Y, Sun J, Han D, Yuan X, Wang Y, Guo Y, Zhong X, Shi J. An open-label randomized multi-Centre study to evaluate anterior controllable Antedisplacement and fusion versus posterior Laminoplasty in patients with cervical ossification of the posterior longitudinal ligament: study design and analysis plan (STAR). BMC Musculoskelet Disord. 2021 Sep 8;22(1):765. doi: 10.1186/s12891-021-04645-3.
Results Reference
derived

Learn more about this trial

Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament

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